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FDA Drug Application 020007 by NOVARTIS PHARMS CORP

Application Number020007
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/4/1991N17205000Pediatric Written Request  http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020007_Zofran_Pediatric_Written_Request.pdf 7/9/2007
AP01/4/1991N31020000Other Important Information from FDA  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm271924.htm 12/20/2011
AP02/2/1993SLR       
AP02/2/1993SLR       
AP02/2/1993SE2       
AP02/2/1993SLR       
AP08/13/1993SE1       
AP08/18/1992SCS       
AP02/2/1993SLR       
AP02/2/1993SLR       
AP012/10/1993SCF       
AP01/22/1993SCS       
AP03/24/1993SCS       
AP02/9/1993SCS       
AP04/28/1993SLR       
AP01/31/1995SCF       
AP03/31/1994SCM       
AP04/27/1994SLR       
AP02/14/1995SCM       
AP07/29/1996SCP       
AP05/16/1996SE1       
AP03/12/1996SLR       
AP010/31/1997SE34359022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-007s022_Zofran.cfm 10/31/1997
AP04/2/1997SLR       
AP08/12/1997SCM       
AP03/10/1999SLR       
AP02/17/1999SLR       
AP05/14/1999SCM       
AP04/11/2000SLR21617030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020007_s030_Zofran_Injection.pdf 1/12/2009
AP012/8/2000SLR       
AP012/8/2000SLR       
AP011/24/2004SLR10655034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20007s034,20403s013ltr.pdf 12/2/2004
AP011/24/2004SLR10699034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf 12/3/2004
AP03/25/2005SE511322035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20007s035ltr.pdf 3/30/2005
AP03/25/2005SE511323035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20007s035lbl.pdf 3/30/2005
AP012/27/2005SLR13329037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf 1/5/2006
AP012/27/2005SLR23327037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020007_s037_Zofran Inj.pdf 9/16/2009
AP08/22/2006SLR14750039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf 8/23/2006
AP08/22/2006SLR14887039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020007s039;020403s016ltr.pdf 9/18/2006
AP09/22/2010SLR26549040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020007s040,020403s018ltr.pdf 9/28/2010
AP09/22/2010SLR26577040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf 9/29/2010
AP07/7/2011SLR29506041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019ltr.pdf 7/13/2011
AP09/14/2011SLR29989042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s042,020403s020ltr.pdf 9/16/2011
AP09/14/2011SLR30014042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf 9/16/2011
AP011/14/2012SLR34401043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020007s043lbl.pdf 11/15/2012
AP011/14/2012SLR34407043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020007Orig1s043ltr.pdf 11/16/2012
AP012/10/2013SLR37997044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020007s044lbl.pdf 12/11/2013
AP012/10/2013SLR38037044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020103Orig1s031,020605Orig1s015,020781Orig1s015,020007Orig1s044ltr.pdf 12/13/2013
AP09/18/2014SLR40536046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020007s046lbl.pdf 9/22/2014
AP09/18/2014SLR40557046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020007Orig1s046ltr.pdf 9/23/2014




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