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FDA Drug Application 021285 by NOVARTIS

Application Number021285
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP05/25/2001N4089000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-285_Trileptal_Approv.pdf 5/29/2001
AP05/25/2001N4090000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21285lbl.pdf 5/29/2001
AP05/25/2001N4091000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-285_Trileptal.cfm 4/30/2002
AP05/25/2001N7217000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm 3/16/2007
AP05/25/2001N28244000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246799.pdf 3/15/2011
AP01/18/2002SCM       
AP04/1/2002SLR4085002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21014s006ltr.pdf 4/1/2002
AP09/10/2002SCS       
AP03/25/2005SLR11316007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21014s012,21285s007ltr.pdf 3/30/2005
AP03/25/2005SLR11317007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21014s012,21285s007lbl.pdf 3/30/2005
AP010/26/2005SE512983008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021014s013lbl.pdf 10/28/2005
AP010/26/2005SE513002008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s013,021285s008rel2_ltr.pdf 11/1/2005
AP03/3/2011SLR28277009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28166009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 3/8/2011
AP03/3/2011SLR28167013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 3/8/2011
AP03/3/2011SLR28278013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP08/31/2007SLR17763014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021014s021, 021285s014ltr.pdf 9/6/2007
AP03/3/2011SLR28279015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28168015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 3/8/2011
AP03/3/2011SLR28169018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 3/8/2011
AP03/3/2011SLR28280018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28281019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28170019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 3/8/2011
AP03/3/2011SLR28171020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 3/8/2011
AP03/3/2011SLR28282020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP04/23/2009SLR22398021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021014s026,021285s021ltr.pdf 5/4/2009
AP04/23/2009SLR22525021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021014s026,021285s021lbl.pdf 5/12/2009
AP03/3/2011SLR28283022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28172022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s015,s019,s022,s024,s025,s027,s028,021285s009,s013,s015,s018,s019,s020,s022ltr.pdf 3/8/2011
AP02/8/2013SLR35133023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021014Orig1s029,021285Orig1s023ltr.pdf 2/12/2013
AP02/8/2013SLR35151023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021014s029,021285s023lbl.pdf 2/12/2013
AP010/30/2011SLR30570025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s031,021285s025ltr.pdf 11/14/2011
AP07/3/2014SLR39787027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s033,021285Orig1s027ltr.pdf 7/8/2014
AP07/3/2014SLR39802027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s033,021285s027lbl.pdf 7/8/2014
AP02/28/2014SCM       
AP05/8/2014SCM       
AP06/6/2014SLR39461030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s035,021285Orig1s030ltr.pdf 6/10/2014
AP06/6/2014SLR39480030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s035,021285s030lbl.pdf 6/10/2014




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