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FDA Drug Application 016295 by BRISTOL MYERS SQUIBB

Application Number016295
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
AP012/7/1967N       
AP05/3/1977SCS       
AP02/19/1980SCS       
AP09/24/1996SLR       
AP03/19/1987SCS       
AP07/16/1985SCM       
AP03/19/1987SCS       
AP05/10/1988SCF       
AP08/25/1988SCS       
AP09/5/1995SCS       
AP07/31/1992SCS       
AP03/9/1993SCF       
AP09/24/1996SLR       
AP010/15/1996SCS       
AP011/25/1996SCP       
AP08/11/1999SLR       
AP04/7/1997SCM       
AP05/23/1997SCM       
AP02/25/1998SE1       
AP02/25/1998SCS       
AP011/10/1998SCM       
AP01/12/2000SLR       
AP04/4/2001SLR2270034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16295S34ltr.pdf 4/4/2001
AP02/20/2001SLR       
AP06/26/2003SE26031036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16295se2-036ltr.pdf 7/6/2003
AP06/26/2003SE26081036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-036_droxia_lbl.pdf 7/8/2003
AP06/26/2003SE28335036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/16-295S036_Droxia.cfm 4/14/2004
AP02/19/2004SLR7775037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16295slr037ltr.pdf 3/2/2004
AP02/19/2004SLR8185037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf 4/5/2004
AP09/19/2006SLR14905039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016295s039, 016295s036ltr.pdf 9/20/2006
AP09/19/2006SLR14917039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016295s039s036lbl.pdf 9/20/2006
AP05/7/2010SLR25523040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016295s040ltr.pdf 5/12/2010
AP05/7/2010SLR25571040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016295s040lbl.pdf 5/17/2010
AP01/26/2012SLR31579041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf 1/30/2012
AP01/26/2012SLR31615041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf 1/31/2012
AP01/26/2012SLR31616042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf 1/31/2012
AP01/26/2012SLR31580042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf 1/30/2012
AP07/16/2015SLR43405045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf 7/17/2015
AP07/16/2015SLR43407045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s045ltr.pdf 7/20/2015
AP07/16/2015SLR43408046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s046ltr.pdf 7/20/2015
AP07/16/2015SLR43406046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s046lbl.pdf 7/17/2015
AP03/23/2016SLR45506047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016295Orig1s047,s048ltr.pdf 3/25/2016
AP03/23/2016SLR45509047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf 3/28/2016
AP03/23/2016SLR45510048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf 3/28/2016




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