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FDA Drug Application 016466 by SANDOZ

Application Number016466
Application Type New Drug Application
Sponsor ApplicantSANDOZ
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
AP07/29/1969N       
AP04/18/1979SLR       
AP04/13/1979SLR       
AP04/18/1979SCF       
AP08/4/1978SCE       
AP010/7/1980SCM       
AP06/12/1985SLR       
AP05/30/1990SCP       
AP011/26/1991SCS       
AP01/6/1992SCS       
AP09/7/1993SLR       
AP01/30/2006SLR13584027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016466s027ltr.pdf 2/2/2006
AP01/30/2006SLR13586027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016466s027lbl.pdf 2/7/2006
AP08/4/1994SCS       
AP09/8/1995SCS       
AP01/18/1996SCS       
AP010/25/1999SCS       
AP02/12/2002SCS       
AP03/1/2007SLR15976036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016466s036ltr.pdf 3/7/2007
AP03/1/2007SLR15992036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016466s036lbl.pdf 3/7/2007
AP06/3/2009SLR22692040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf 6/4/2009
AP06/3/2009SLR22712040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf 6/8/2009
AP06/3/2009SLR22713041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf 6/8/2009
AP06/3/2009SLR22693041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf 6/4/2009
AP09/4/2014SCM       
AP07/3/2014SLR39781046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016466Orig1s046ltr.pdf 7/8/2014
AP07/3/2014SLR39807046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016466s046lbl.pdf 7/8/2014




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