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FDA Drug Application 016267 by NOVARTIS

Application Number016267
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/1/1968N       
AP01/20/1976SLR       
AP03/4/1977SOA       
AP01/25/1978SCS       
AP04/6/1978SCM       
AP06/4/1979SES       
AP06/4/1979SLR       
AP07/8/1980SCP       
AP09/2/1980SCM       
AP04/17/1986SPD       
AP04/6/1984SCS       
AP01/4/1984SCP       
AP01/8/1986SCS       
AP09/27/1985SCS       
AP02/13/1987SLR       
AP09/8/1987SLR       
AP02/12/1990SCP       
AP01/30/1998SCM       
AP01/30/1998SCS       
AP08/31/1994SLR       
AP06/19/1995SLR       
AP04/2/1997SLR       
AP012/22/1998SCM       
AP012/22/1998SCP       
AP012/22/1998SCM       
AP010/23/1998SCM       
AP05/25/2000SCP       
AP04/9/2001SLR1663034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16267S34ltr.pdf 4/9/2001
AP04/28/2000SCM       
AP01/5/2001SCS       
AP04/24/2002SCS       
AP07/5/2001SCS       
AP02/14/2002SLR1662039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16267s39ltr.pdf 2/14/2002
AP01/15/2002SCM       
AP01/19/2007SLR15699044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016267s044lbl.pdf 1/24/2007
AP01/19/2007SLR15707044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016267s044ltr.pdf 1/25/2007
AP01/28/2009SLR21685045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016267s045ltr.pdf 1/30/2009
AP01/28/2009SLR21748045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016267s045lbl.pdf 2/4/2009
AP09/7/2010SLR26440047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016267s047ltr.pdf 9/9/2010
AP09/7/2010SLR26451047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016267s047lbl.pdf 9/10/2010
AP012/16/2011SLR31090050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016267s050lbl.pdf 12/20/2011
AP012/16/2011SLR31148050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016267s050ltr.pdf 12/21/2011
AP06/14/2013SCM       
AP04/27/2016SCM       




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