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FDA Drug Application 021014 by NOVARTIS

Application Number021014
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP01/14/2000N4086000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21014ltr.pdf 1/10/1999
AP01/14/2000N4087000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21014lbl.pdf 1/10/1999
AP01/14/2000N4088000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-014_Trileptal.cfm 2/28/2002
AP01/14/2000N7216000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm 3/16/2007
AP01/14/2000N28243000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246799.pdf 3/15/2011
AP06/2/2000SCM       
AP08/29/2000SCS       
AP08/7/2003SE56505003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21014se5-003_trileptal_lbl.pdf 8/15/2003
AP08/7/2003SE56528003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21014se5-003ltr.pdf 8/15/2003
AP08/7/2003SE514195003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021014_s003_TrileptalTOC.cfm 5/31/2006
AP011/14/2001SCM       
AP05/1/2002SCP       
AP04/1/2002SLR4084006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21014s006ltr.pdf 4/1/2002
AP03/27/2003SCS5278007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21014scs007ltr.pdf 4/15/2003
AP03/25/2005SLR11314012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21014s012,21285s007ltr.pdf 3/30/2005
AP03/25/2005SLR11315012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21014s012,21285s007lbl.pdf 3/30/2005
AP010/26/2005SE512984013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021014s013lbl.pdf 10/28/2005
AP010/26/2005SE513003013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s013,021285s008rel2_ltr.pdf 11/1/2005
AP011/9/2005SCS13094014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021014s014ltr.pdf 11/18/2005
AP03/3/2011SLR28159015   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
AP03/3/2011SLR28284015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28285019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28160019   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
AP06/19/2007SLR17764021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021014s021, 021285s014ltr.pdf 9/6/2007
AP18/31/2007SLR17764021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021014s021, 021285s014ltr.pdf 9/6/2007
AP03/3/2011SLR28161022   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
AP03/3/2011SLR28286022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28287024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28162024   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
AP03/3/2011SLR28163025   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
AP03/3/2011SLR28288025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP04/23/2009SLR22397026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021014s026,021285s021ltr.pdf 5/4/2009
AP04/23/2009SLR22524026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021014s026,021285s021lbl.pdf 5/12/2009
AP03/3/2011SLR28164027   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
AP03/3/2011SLR28289027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28290028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028,021285s009s013s015s018s019s020s022lbl.pdf 3/21/2011
AP03/3/2011SLR28165028   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
AP02/8/2013SLR35132029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021014Orig1s029,021285Orig1s023ltr.pdf 2/12/2013
AP02/8/2013SLR35152029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021014s029,021285s023lbl.pdf 2/12/2013
AP010/30/2011SLR30571031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021014s031,021285s025ltr.pdf 11/14/2011
AP07/3/2014SLR39786033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s033,021285Orig1s027ltr.pdf 7/8/2014
AP07/3/2014SLR39801033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s033,021285s027lbl.pdf 7/8/2014
AP05/8/2014SCM       
AP06/6/2014SLR39460035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021014Orig1s035,021285Orig1s030ltr.pdf 6/10/2014
AP06/6/2014SLR39481035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021014s035,021285s030lbl.pdf 6/10/2014
AP04/14/2015SCM       
AP06/17/2016SCM       
AP05/6/2016SCM       




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