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FDA Drug Application 050632 by BRISTOL MYERS SQUIBB

Application Number050632
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
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
AP05/24/1989N       
AP06/25/1992SLR       
AP09/30/1991SLR       
AP08/20/1996SLR       
AP08/20/1996SLR       
AP010/10/1996SCP       
AP02/16/1999SLR       
AP012/24/1998SE1812010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50632s10ltr.pdf 12/24/1998
AP012/24/1998SE1813010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50632s010.cfm 12/24/1998
AP012/24/1998SE1814010   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50623s10lbl.pdf 12/24/1998
AP03/25/2002SLR4613011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50580s033ltr.pdf 3/25/2002
AP012/16/2004SLR10846012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50580s037,50632s012ltr.pdf 12/30/2004
AP01/22/2008SLR18945013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050632s013ltr.pdf 1/24/2008
AP01/22/2008SLR18950013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.pdf 1/24/2008
AP06/17/2013SLR36302015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050632s015lbl.pdf 6/17/2013
AP06/17/2013SLR36341015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050632Orig1s015ltr.pdf 6/18/2013
AP07/12/2013SCM       
AP07/25/2014SCM       




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