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FDA Drug Application 016885 by BRISTOL MYERS SQUIBB

Application Number016885
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
AP07/8/1970N       
AP04/24/1978SCS       
AP012/24/1985SLR       
AP011/28/1978SCE       
AP09/29/1986SCS       
AP08/26/1985SCS       
AP08/6/1985SCS       
AP09/20/1985SLR       
AP07/21/1986SCM       
AP06/30/1986SLR       
AP04/2/1987SCM       
AP07/1/1987SLR       
AP01/8/1992SCM       
AP09/4/1997SLR       
AP03/29/1999SCM       
AP07/10/2003SLR6156022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16885slr022ltr.pdf 7/28/2003
AP07/10/2003SLR21566022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016885_S022_Lysodren.pdf 1/12/2009
AP02/10/2009SLR21814023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016885s023lbl.pdf 2/12/2009
AP02/10/2009SLR21834023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016885s023ltr.pdf 2/13/2009
AP011/15/2013SLR37839025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016885Orig1s025ltr.pdf 11/18/2013
AP011/15/2013SLR37896025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016885s025lbl.pdf 11/22/2013
AP03/11/2016SLR45439026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016885Orig1s026ltr.pdf 3/15/2016
AP03/11/2016SLR45445026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016885s026lbl.pdf 3/15/2016




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