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FDA Drug Application 020781 by NOVARTIS PHARMS CORP

Application Number020781
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/27/1999N230000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20781ltr.pdf 1/27/1999
AP01/27/1999N231000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20781_Zofran.pdf 1/27/1999
AP01/27/1999N232000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20781lbl.pdf 1/27/1999
AP01/27/1999N31023000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm271924.htm 12/20/2011
AP04/11/2000SLR18091001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020781_S001_ZOFRAN.pdf 9/26/2007
AP012/13/2000SLR       
AP01/31/2003SLR9662003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20103slr021,20781slr003ltr.pdf 7/1/2004
AP011/24/2004SLR10695007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20103s023,20605s007,20781s007ltr.pdf 12/2/2004
AP011/24/2004SLR10703007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf 12/3/2004
AP012/27/2005SLR13364008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020103s025,020781s008, 020605s008rev2.pdf 1/6/2006
AP08/22/2006SLR14751010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf 8/23/2006
AP08/22/2006SLR14883010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020103s027,020605s010,020781s010ltr.pdf 9/18/2006
AP09/22/2010SLR26547013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020103s029,020605s013,020781s013ltr.pdf 9/27/2010
AP09/22/2010SLR26578013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf 9/29/2010
AP09/14/2011SLR29993014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020103s030,020605s014,020781s014ltr.pdf 9/16/2011
AP09/14/2011SLR30012014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf 9/16/2011
AP012/10/2013SLR37996015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf 12/11/2013
AP012/10/2013SLR38036015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf 12/13/2013
AP09/28/2016SLR47222017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s033,020605s017,020781s017lbl.pdf 9/29/2016
AP09/28/2016SLR47227017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s033,020605Orig1s017,020781Orig1s017ltr.pdf 9/30/2016
AP09/18/2014SLR40537018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf 9/22/2014
AP09/18/2014SLR40556018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020103Orig1s034,020605Orig1s018,020781Orig1s018ltr.pdf 9/23/2014




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