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FDA Drug Application 206352 by BRISTOL MYERS SQUIBB

Application Number206352
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/2/2014N39430000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206352Orig1s000,21567Orig1s035ltr.pdf 6/3/2014
AP06/2/2014N39433000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.pdf 6/3/2014
AP06/2/2014N42442000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035TOC.cfm 4/7/2015
AP06/2/2014N42445000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035SumR.pdf 4/7/2015
AP03/27/2015SLR42350002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s037,206352Orig1s002ltr.pdf 4/1/2015
AP03/27/2015SLR42401002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf 4/2/2015
AP09/24/2015SE844012003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206352Orig1s003,021567Orig1s038ltr.pdf 9/28/2015
AP09/24/2015SE844734003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.pdf 12/10/2015
AP09/15/2016SLR47090004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021567Orig1s039,206352Orig1s004ltr.pdf 9/20/2016
AP09/15/2016SLR47107004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021567s039,206352s004lbl.pdf 9/20/2016




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