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FDA Drug Application 019201 by NOVARTIS

Application Number019201
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/28/1988N24202000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089822.pdf 12/4/2009
AP07/20/1989SCS       
AP07/11/1989SCS       
AP02/6/1989SCM       
AP012/30/1988SLR       
AP02/12/1991SCS       
AP09/27/1989SCP       
AP02/12/1990SCS       
AP01/24/1990SLR       
AP04/21/1992SCS       
AP04/20/1993SCM       
AP01/4/1993SCS       
AP012/8/1994SCS       
AP011/26/2002SLR2823018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19201slr018ltr.pdf 11/26/2002
AP011/26/2002SLR11094018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-201s018_Voltaren.cfm 2/8/2005
AP011/2/1995SCM       
AP07/28/1995SLR       
AP012/22/1995SCM       
AP04/20/1998SLR       
AP010/31/2001SLR       
AP03/11/1997SCS       
AP05/16/1997SCM       
AP02/9/1999SCM       
AP04/22/1999SCP       
AP02/18/2000SCM       
AP09/20/2000SCS       
AP010/23/2000SCM       
AP09/28/2001SCS       
AP03/11/2002SCM       
AP09/19/2002SCS       
AP01/24/2006SLR13480035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019201s035lbl.pdf 1/25/2006
AP01/24/2006SLR13537035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf 1/30/2006
AP07/9/2007SLR17270036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019201s036lbl.pdf 7/10/2007
AP07/9/2007SLR17283036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019201s036ltr.pdf 7/16/2007
AP02/25/2009SLR21915038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019201s038ltr.pdf 2/27/2009
AP02/25/2009SLR22015038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019201s038lbl.pdf 3/17/2009
AP02/23/2011SLR27983039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf 2/28/2011
AP02/23/2011SLR28040039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf 3/4/2011
AP02/23/2011SLR28041040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf 3/4/2011
AP02/23/2011SLR27984040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf 2/28/2011
AP01/25/2013SCM       
AP06/5/2014SCM       
AP05/9/2016SLR45966046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf 5/11/2016
AP05/9/2016SLR46003046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019201Orig1s046ltr.pdf 5/12/2016




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