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FDA Drug Application 020844 by JANSSEN PHARMS

Application Number020844
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/26/1998N369000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20844ltr.pdf 10/26/1998
AP010/26/1998N370000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20844lbl.pdf 10/26/1998
AP010/26/1998N10185000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020844s000_Topamax.cfm 9/15/2004
AP010/26/1998N23473000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152837.pdf 9/30/2009
AP07/23/1999SE13994001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S1_Topamax.cfm 7/3/2000
AP07/23/1999SE15123001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S1_Topamax_appltr_prntlbl.pdf 7/23/1999
AP07/23/1999SE15124001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S1_Topamax_appltr_prntlbl.pdf 7/23/1999
AP05/1/2000SLR       
AP010/1/1999SE13989004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S4_Topamax.cfm 7/3/2000
AP01/4/2000SCM       
AP012/16/2003SLR7449006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf 12/29/2003
AP012/16/2003SLR9581006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf 6/28/2004
AP010/26/2000SCM       
AP010/24/2000SCM       
AP02/23/2001SCM       
AP08/28/2001SE13991010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20505S002ltr.pdf 8/28/2001
AP08/28/2001SE13992010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20505S002lbl.pdf 8/28/2001
AP08/28/2001SE110152010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-505s002_20-844s010_Topamax.cfm 9/8/2004
AP012/22/2009SLR24369011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf 12/30/2009
AP012/22/2009SLR24401011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf 1/4/2010
AP06/3/2003SLR5813012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr015,20844slr012ltr.pdf 6/8/2003
AP011/26/2002SLR3988013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20505slr013,20844slr016ltr.pdf 11/26/2002
AP012/16/2003SE27280014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf 12/19/2003
AP012/16/2003SE27450014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf 12/29/2003
AP06/29/2005SE111931015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020844s015S022lbl.pdf 7/5/2005
AP06/29/2005SE111944015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf 7/8/2005
AP012/16/2003SLR7281016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20844slr006,016,se2-014,20505slr010,19se2-017ltr.pdf 12/19/2003
AP012/16/2003SLR7451016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf 12/29/2003
AP06/12/2003SLR5959017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr020,20844slr017ltr.pdf 6/22/2003
AP04/15/2003SLR6236018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf 7/30/2003
AP08/11/2004SE110008019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf 8/12/2004
AP08/11/2004SE110017019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20505s022,025,20844s019,021lbl.pdf 8/12/2004
AP04/15/2003SLR6237020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20505slr021,023,20844slr018,020ltr.pdf 7/30/2003
AP08/11/2004SLR10009021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20505s022,025,20844s019,021ltr.pdf 8/12/2004
AP06/29/2005SLR11932022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020844s015S022lbl.pdf 7/5/2005
AP06/29/2005SLR11945022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020505s018,026,020844s015,022ltr.pdf 7/8/2005
AP010/19/2006SLR15150024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020505s029,020844s024pi.pdf 10/23/2006
AP010/19/2006SLR15178024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020505s029, 020844s024ltr.pdf 10/23/2006
AP012/22/2009SLR24370026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf 12/30/2009
AP012/22/2009SLR24402026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf 1/4/2010
AP012/22/2009SLR24371027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf 12/30/2009
AP012/22/2009SLR24403027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf 1/4/2010
AP04/22/2009SLR22323030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s036,020844s030ltr.pdf 4/27/2009
AP04/22/2009SLR22335030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s036,020844s030lbl.pdf 4/28/2009
AP012/22/2009SE524372031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s014,s031,s032,s037,020844s011,s026,s027,s031ltr.pdf 12/30/2009
AP012/22/2009SE524404031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s014s031s032s037,020844s011s026s027s031lbl.pdf 1/4/2010
AP04/23/2009SLR22395032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf 5/4/2009
AP04/23/2009SLR22539032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf 5/12/2009
AP04/23/2009SLR22396034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020505s038,s039,020844s032,s034ltr.pdf 5/4/2009
AP04/23/2009SLR22540034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf 5/12/2009
AP03/4/2011SLR28074035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037lbl.pdf 3/4/2011
AP03/4/2011SLR28076035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s040s045,020844s035s037MedG.pdf 3/4/2011
AP03/4/2011SLR28157035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s040,s045,020844s035,s037ltr.pdf 3/8/2011
AP07/15/2011SE529533036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036MedG.pdf 7/18/2011
AP07/15/2011SE529536036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042,020844s036lbl.pdf 7/18/2011
AP07/15/2011SE529540036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020505s042,20844s36ltr.pdf 7/19/2011
AP010/29/2012SLR34206041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020844s041lbl.pdf 10/29/2012
AP010/29/2012SLR34211041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020505Orig1s050,020844Orig1s041ltr.pdf 11/1/2012
AP03/28/2014SE838937043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s052,020844s043lbl.pdf 4/1/2014
AP03/28/2014SE838950043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s052,020844Orig1s043ltr.pdf 4/2/2014
AP01/29/2014SLR38401044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s053,020844Orig1s044ltr.pdf 1/30/2014
AP01/29/2014SLR38413044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s053,020844s044lbl.pdf 1/31/2014
AP010/21/2014SLR40865045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s054,020844Orig1s045ltr.pdf 10/23/2014
AP010/21/2014SLR40866045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s054,020844s045lbl.pdf 10/23/2014
AP012/18/2014SLR41329046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020505s055,020844s046lbl.pdf 12/19/2014
AP012/18/2014SLR41338046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020505Orig1s055,020844Orig1s046ltr.pdf 12/19/2014




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