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FDA Drug Application 020254 by NOVARTIS

Application Number020254
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/8/1996N       
AP05/21/1996SCM       
AP010/31/2001SLR       
AP03/11/1997SCS       
AP05/16/1997SCM       
AP04/22/1999SCP       
AP02/18/2000SCM       
AP09/20/2000SCM       
AP012/13/2000SCS       
AP010/23/2000SCM       
AP09/28/2001SCS       
AP011/5/2001SCS       
AP03/11/2002SCM       
AP09/19/2002SCS       
AP01/24/2006SLR13478016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020254s016lbl.pdf 1/25/2006
AP01/24/2006SLR13539016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf 1/30/2006
AP01/24/2006SLR44392016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020254Orig1s016.pdf 11/5/2015
AP02/25/2009SLR21919018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020254s018ltr.pdf 2/27/2009
AP02/25/2009SLR22017018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020254s018.pdf 3/17/2009
AP02/23/2011SLR27979019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf 2/28/2011
AP02/23/2011SLR28044019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf 3/4/2011
AP02/23/2011SLR28045020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf 3/4/2011
AP02/23/2011SLR27982020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf 2/28/2011
AP01/25/2013SCM       
AP02/28/2014SCM       
AP06/5/2014SCM       
AP05/9/2016SLR45967028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf 5/11/2016
AP05/9/2016SLR46005028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020254Orig1s028ltr.pdf 5/12/2016
AP05/9/2016SLR46055028   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501669.pdf 5/18/2016




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