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FDA Drug Application 020103 by NOVARTIS PHARMS CORP

Application Number020103
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1992N31021000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm271924.htm 12/20/2011
AP02/22/1993SLR       
AP09/28/1993SCS       
AP04/4/1994SLR       
AP09/26/1994SE1       
AP04/19/1995SE1       
AP04/15/1994SCM       
AP04/27/1994SLR       
AP04/10/1995SE213331008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf 1/5/2006
AP02/14/1995SCM       
AP05/17/1995SCM       
AP011/16/1995SLR       
AP04/15/1997SLR       
AP08/27/1999SE11015015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran.cfm 8/27/1999
AP08/27/1999SE19663015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran_appltr.pdf 7/1/2004
AP08/27/1999SCF1028016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20103S15_Zofran.cfm 8/27/1999
AP04/11/2000SLR17887017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020103_S017_ZOFRAN.pdf 9/14/2007
AP012/13/2000SLR1497018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20781S2LTR.PDF 12/13/2000
AP012/13/2000SLR1498018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20781S2LBL.PDF 12/13/2000
AP010/24/2001SCP       
AP010/24/2001SCS       
AP01/31/2003SLR9661021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20103slr021,20781slr003ltr.pdf 7/1/2004
AP011/24/2004SLR10693023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20103s023,20605s007,20781s007ltr.pdf 12/2/2004
AP011/24/2004SLR10701023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20103s023,20605s007,20781s007lbl.pdf 12/3/2004
AP02/18/2005SCS11153024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20103s024ltr.pdf 2/23/2005
AP02/18/2005SCS11169024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20103s024lbl.pdf 2/23/2005
AP02/18/2005SCS23329024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020103_s024_Zofran Tabs.pdf 9/16/2009
AP012/27/2005SLR13332025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020103s008s025,020605s008lbl.pdf 1/5/2006
AP012/27/2005SLR13365025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020103s025,020781s008, 020605s008rev2.pdf 1/6/2006
AP012/27/2005SLR23330025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020103_s025_Zofran Inj.pdf 9/16/2009
AP08/22/2006SLR14753027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020103s27,020605s10,020781s10lbl.pdf 8/23/2006
AP08/22/2006SLR14885027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020103s027,020605s010,020781s010ltr.pdf 9/18/2006
AP09/22/2010SLR26545029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020103s029,020605s013,020781s013ltr.pdf 9/27/2010
AP09/22/2010SLR26580029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020103s029,020605s013,020781s013lbl.pdf 9/29/2010
AP09/14/2011SLR29991030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020103s030,020605s014,020781s014ltr.pdf 9/16/2011
AP09/14/2011SLR30010030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020103s030,020605s014,020781s014lbl.pdf 9/16/2011
AP012/10/2013SLR37994031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020103s031,020605s015,020781s015lbl.pdf 12/11/2013
AP012/10/2013SLR38034031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf 12/13/2013
AP09/28/2016SLR47220033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s033,020605s017,020781s017lbl.pdf 9/29/2016
AP09/28/2016SLR47225033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020103Orig1s033,020605Orig1s017,020781Orig1s017ltr.pdf 9/30/2016
AP09/18/2014SLR40539034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020103s034,020605s018,020781s018lbl.pdf 9/22/2014
AP09/18/2014SLR40554034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020103Orig1s034,020605Orig1s018,020781Orig1s018ltr.pdf 9/23/2014




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