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FDA Drug Application 020605 by NOVARTIS PHARMS CORP

Application Number020605
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/24/1997N4361000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020605ap.pdf 1/24/1997
AP01/24/1997N31022000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm271924.htm 12/20/2011
AP04/15/1997SLR       
AP01/26/1999SCM       
AP04/11/2000SLR18102004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020605_S004_ZOFRAN.pdf 9/26/2007
AP012/13/2000SLR2128005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20781S2LTR.PDF 12/13/2000
AP012/13/2000SLR2130005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF 12/13/2000
AP011/24/2004SLR10694007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20103s023,20605s007,20781s007ltr.pdf 12/2/2004
AP011/24/2004SLR10702007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf 12/3/2004
AP012/27/2005SLR13333008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf 1/5/2006
AP012/27/2005SLR13363008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020103s025,020781s008, 020605s008rev2.pdf 1/6/2006
AP012/27/2005SLR23366008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020605_s008_Zofran Tabs.pdf 9/16/2009
AP08/22/2006SLR14752010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf 8/23/2006
AP08/22/2006SLR14884010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020103s027,020605s010,020781s010ltr.pdf 9/18/2006
AP09/22/2010SLR26546013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020103s029,020605s013,020781s013ltr.pdf 9/27/2010
AP09/22/2010SLR26579013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf 9/29/2010
AP09/14/2011SLR29992014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020103s030,020605s014,020781s014ltr.pdf 9/16/2011
AP09/14/2011SLR30011014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf 9/16/2011
AP012/10/2013SLR37995015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf 12/11/2013
AP012/10/2013SLR38035015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf 12/13/2013
AP09/28/2016SLR47221017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s033,020605s017,020781s017lbl.pdf 9/29/2016
AP09/28/2016SLR47226017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s033,020605Orig1s017,020781Orig1s017ltr.pdf 9/30/2016
AP09/18/2014SLR40538018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf 9/22/2014
AP09/18/2014SLR40555018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020103Orig1s034,020605Orig1s018,020781Orig1s018ltr.pdf 9/23/2014




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