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FDA Drug Application 125554 by BRISTOL MYERS SQUIBB

Application Number125554
Application Type Biologic License Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/22/2014N41351000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125554lbl.pdf 12/22/2014
AP012/22/2014N41402000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125554Orig1s000ltr.pdf 12/24/2014
AP012/22/2014N41660000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125554Orig1s000TOC.cfm 1/21/2015
AP012/22/2014N41661000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125554Orig1s000SumR.pdf 1/21/2015
AP011/23/2015S44573001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s001ltr.pdf 11/24/2015
AP011/23/2015S44585001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s001lbl.pdf 11/25/2015
AP09/30/2015S44066002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s002lbl.pdf 10/1/2015
AP09/30/2015S44094002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s002ltr.pdf 10/2/2015
AP010/9/2015S44183005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s005lbl.pdf 10/9/2015
AP010/9/2015S44202005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s005ltr.pdf 10/14/2015
AP01/23/2016S45012007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s007ltr.pdf 1/25/2016
AP011/23/2015S44567012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s012lbl.pdf 11/23/2015
AP011/23/2015S44572012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s012ltr.pdf 11/24/2015
AP010/4/2016S47290016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s016lbl.pdf 10/6/2016
AP010/4/2016S47296016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s016ltr.pdf 10/6/2016
AP09/13/2016S47035017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf 9/14/2016
AP09/13/2016S47045017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s017,s018ltr.pdf 9/15/2016
AP09/13/2016S47036018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf 9/14/2016
AP09/13/2016S47046018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s017,s018ltr.pdf 9/15/2016
AP05/17/2016S46036019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s019lbl.pdf 5/17/2016
AP05/17/2016S46063019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s019ltr.pdf 5/19/2016




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