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FDA Drug Application 020505 by JANSSEN PHARMS

Application Number020505
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/1996N10179000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020505s000_Topamax.cfm 9/10/2004
AP012/24/1996N23472000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152837.pdf 9/30/2009
AP07/23/1999SE1518001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax.cfm 7/3/2000
AP07/23/1999SE15125001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax_appltr_prntlbl.pdf 7/23/1999
AP07/23/1999SE15126001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S1_Topamax_appltr_prntlbl.pdf 7/23/1999
AP08/28/2001SE13990002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20505S002ltr.pdf 8/28/2001
AP08/28/2001SE13993002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20505S002lbl.pdf 8/28/2001
AP08/28/2001SE110151002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-505s002_20-844s010_Topamax.cfm 9/8/2004
AP010/1/1999SE1519003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax.cfm 7/3/2000
AP010/1/1999SE15121003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_appltr_prntlbl.pdf 10/1/1999
AP010/1/1999SE15122003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_appltr_prntlbl.pdf 10/1/1999
AP05/1/2000SLR       
AP03/2/2000SCM       
AP012/7/1999SCM       
AP01/4/2000SCM       
AP012/16/2003SLR7452010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf 12/29/2003
AP012/16/2003SLR9580010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf 6/28/2004
AP05/15/2000SCS       
AP07/18/2000SCM       
AP010/24/2000SCM       
AP012/22/2009SLR24365014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf 12/30/2009
AP012/22/2009SLR24397014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf 1/4/2010
AP06/3/2003SLR5812015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr015,20844slr012ltr.pdf 6/8/2003
AP011/26/2002SLR3987016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20505slr013,20844slr016ltr.pdf 12/9/2002
AP012/16/2003SE27282017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf 12/19/2003
AP012/16/2003SE27453017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf 12/29/2003
AP06/29/2005SE111929018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020505s018lbl.pdf 7/5/2005
AP06/29/2005SE111946018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf 7/8/2005
AP06/29/2005SE131918018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020505Orig1s018.pdf 2/28/2012
AP012/16/2003SLR7283019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf 12/19/2003
AP012/16/2003SLR7454019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf 12/29/2003
AP06/12/2003SLR5958020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr020,20844slr017ltr.pdf 6/22/2003
AP04/15/2003SLR5688021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf 5/29/2003
AP08/11/2004SE110006022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf 8/12/2004
AP08/11/2004SE110015022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf 8/12/2004
AP04/15/2003SLR5689023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf 5/29/2003
AP08/11/2004SLR10007025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf 8/12/2004
AP08/11/2004SLR10016025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf 8/12/2004
AP06/29/2005SLR11930026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020505s018lbl.pdf 7/5/2005
AP06/29/2005SLR11947026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf 7/8/2005
AP010/19/2006SLR15151029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020505s029,020844s024pi.pdf 10/23/2006
AP010/19/2006SLR15179029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020505s029, 020844s024ltr.pdf 10/23/2006
AP012/22/2009SLR24366031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf 12/30/2009
AP012/22/2009SLR24398031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf 1/4/2010
AP012/22/2009SLR24367032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf 12/30/2009
AP012/22/2009SLR24399032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf 1/4/2010
AP04/22/2009SLR22334036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s036,020844s030lbl.pdf 4/28/2009
AP012/22/2009SE524368037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf 12/30/2009
AP012/22/2009SE524400037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf 1/4/2010
AP04/23/2009SLR22393038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf 5/4/2009
AP04/23/2009SLR22537038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf 5/12/2009
AP04/23/2009SLR22394039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf 5/4/2009
AP04/23/2009SLR22538039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf 5/12/2009
AP03/4/2011SLR28078040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf 3/4/2011
AP03/4/2011SLR28080040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037MedG.pdf 3/4/2011
AP03/4/2011SLR28155040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844s035,s037ltr.pdf 3/8/2011
AP07/15/2011SE829534042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036MedG.pdf 7/18/2011
AP07/15/2011SE829535042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036lbl.pdf 7/18/2011
AP07/15/2011SE829539042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s042,20844s36ltr.pdf 7/19/2011
AP03/4/2011SLR28079045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf 3/4/2011
AP03/4/2011SLR28081045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037MedG.pdf 3/4/2011
AP03/4/2011SLR28156045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844s035,s037ltr.pdf 3/8/2011
AP010/29/2012SLR34207050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020505s050lbl.pdf 10/29/2012
AP010/29/2012SLR34210050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020505Orig1s050,020844Orig1s041ltr.pdf 11/1/2012
AP07/25/2013SCM       
AP03/28/2014SE838935052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s052,020844s043lbl.pdf 4/1/2014
AP03/28/2014SE838949052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s052,020844Orig1s043ltr.pdf 4/2/2014
AP01/29/2014SLR38400053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s053,020844Orig1s044ltr.pdf 1/30/2014
AP01/29/2014SLR38414053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s053,020844s044lbl.pdf 1/31/2014
AP010/21/2014SLR40864054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s054,020844Orig1s045ltr.pdf 10/23/2014
AP010/21/2014SLR40867054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s054,020844s045lbl.pdf 10/23/2014
AP012/18/2014SLR41330055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s055,020844s046lbl.pdf 12/19/2014
AP012/18/2014SLR41337055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s055,020844Orig1s046ltr.pdf 12/19/2014
AP05/11/2015SCM       




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