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FDA Drug Application 050580 by BRISTOL MYERS SQUIBB

Application Number050580
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
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
AP012/31/1986N       
AP011/1/1996SE1       
AP09/18/1990SCM       
AP04/10/1989SCG       
AP06/25/1992SLR       
AP09/30/1991SLR       
AP08/20/1996SLR       
AP08/20/1996SLR       
AP05/23/1994SCS       
AP02/18/1993SCS       
AP05/23/1994SCS       
AP04/3/1996SCS       
AP07/28/1998SCS       
AP02/16/1999SLR       
AP06/12/1997SCM       
AP011/7/1997SCM       
AP02/16/1999SLR       
AP012/29/1999SCM       
AP03/25/2002SLR4612033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50580s033ltr.pdf 3/25/2002
AP06/24/2002SCM       
AP09/13/2002SCS       
AP011/27/2002SCM       
AP012/16/2004SLR10845037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50580s037,50632s012ltr.pdf 12/30/2004
AP01/22/2008SLR18947040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050580s040ltr.pdf 1/24/2008
AP01/22/2008SLR18951040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050580s040,050632s013lbl.pdf 1/24/2008
AP06/17/2013SLR36307042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050580s042lbl.pdf 6/17/2013
AP06/17/2013SLR36340042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050580Orig1s042ltr.pdf 6/18/2013
AP09/30/2014SCM       




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