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FDA Drug Application 206353 by BRISTOL-MYERS SQUIBB

Application Number206353
Application Type New Drug Application
Sponsor ApplicantBRISTOL-MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/29/2015N41746000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s000lbl.pdf 1/30/2015
AP01/29/2015N41750000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206353Orig1s000ltr.pdf 2/2/2015
AP01/29/2015N45690000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206353Orig1s000TOC.cfm 4/15/2016
AP01/29/2015N45691000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206353Orig1s000SumR.pdf 4/15/2016
AP07/23/2015SLR43470001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206353Orig1s001ltr.pdf 7/24/2015
AP07/23/2015SLR43488001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206353s001lbl.pdf 7/24/2015
AP07/1/2016SLR46454002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206353Orig1s002ltr.pdf 7/5/2016
AP07/1/2016SLR46465002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206353s002lbl.pdf 7/5/2016




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