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FDA Drug Application 018731 by BRISTOL MYERS SQUIBB

Application Number018731
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
AP09/29/1986N       
AP012/16/1986SCP       
AP012/16/1986SCP       
AP04/23/1987SCM       
AP07/25/1989SCP       
AP07/25/1989SLR       
AP08/10/1987SLR       
AP06/23/1988SCM       
AP011/2/1988SLR       
AP03/2/1989SCS       
AP03/2/1989SCS       
AP010/13/1988SCP       
AP04/28/1989SCM       
AP07/31/1991SLR       
AP01/26/1990SCM       
AP03/2/1998SLR       
AP01/26/1990SCM       
AP010/5/1990SCS       
AP04/22/1996SCF       
AP09/23/1993SLR       
AP04/22/1996SLR       
AP03/20/1996SCS       
AP06/19/1996SCM       
AP04/22/1996SE2       
AP012/30/1996SCP       
AP05/20/1998SLR       
AP05/20/1998SLR       
AP04/3/1998SCP       
AP06/19/1998SCM       
AP01/27/1999SCM       
AP05/3/2001SLR5229039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf 4/14/2003
AP07/27/1999SCP       
AP011/1/1999SCM       
AP04/25/2000SCP       
AP07/19/2001SE58346043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-731S043_review.pdf 4/14/2004
AP07/19/2001SE53818043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18731s43ltr.pdf 7/19/2001
AP07/19/2001SE53819043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s43lbl.pdf 7/19/2001
AP05/3/2001SLR5228045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18731s39s45lbl.pdf 4/14/2003
AP02/7/2002SLR3817046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18731s46ltr.pdf 2/7/2002
AP09/21/2007SLR17952048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018731s048ltr.pdf 9/25/2007
AP09/21/2007SLR18024048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018731s048lbl.pdf 9/26/2007
AP011/22/2010SLR27011051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf 11/22/2010
AP011/22/2010SLR27077051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018731s051ltr.pdf 11/30/2010




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