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FDA Drug Application 020142 by NOVARTIS

Application Number020142
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP011/24/1993N23892000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135935.pdf 11/16/2009
AP01/11/1995SCS       
AP07/6/1994SCM       
AP07/28/1995SLR       
AP011/28/1995SCM       
AP04/20/1998SLR       
AP010/31/2001SLR       
AP05/16/1997SCM       
AP011/12/1997SCS       
AP04/22/1999SCP       
AP07/10/2000SCM       
AP09/15/2000SCM       
AP07/13/2001SCM       
AP03/11/2002SCM       
AP09/19/2002SCS       
AP01/24/2006SLR13479017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020142s017lbl.pdf 1/25/2006
AP01/24/2006SLR13538017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf 1/30/2006
AP02/25/2009SLR21929019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020142s019ltr.pdf 3/3/2009
AP02/25/2009SLR22016019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020142s019lbl.pdf 3/17/2009
AP02/23/2011SLR28042021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf 3/4/2011
AP02/23/2011SLR27980021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020142s021,s022ltr.pdf 2/28/2011
AP02/23/2011SLR27981022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020142s021,s022ltr.pdf 2/28/2011
AP02/23/2011SLR28043022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf 3/4/2011
AP011/24/2014SCM       
AP05/9/2016SLR45965027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020142s027lbl.pdf 5/11/2016
AP05/9/2016SLR46004027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020142Orig1s027ltr.pdf 5/12/2016




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