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FDA Drug Application 202155 by BRISTOL MYERS SQUIBB

Application Number202155
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
AP012/28/2012N34806000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf 12/31/2012
AP012/28/2012N34810000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202155Orig1s000ltr.pdf 1/2/2013
AP012/28/2012N34821000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333961.pdf 1/3/2013
AP012/28/2012N35161000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202155Orig1s000TOC.cfm 2/13/2013
AP07/16/2013SCM       
AP01/30/2014SLR38404002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s002lbl.pdf 1/31/2014
AP01/30/2014SLR38436002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s002ltr.pdf 2/4/2014
AP01/30/2014SLR38871002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202155Orig1s002TOC.cfm 3/21/2014
AP03/13/2014SE838797003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s003ltr.pdf 3/14/2014
AP03/13/2014SE838851003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s003lbl.pdf 3/19/2014
AP010/31/2013SLR37704004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202155Orig1s004ltr.pdf 11/6/2013
AP010/31/2013SLR37858004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202155Orig1s004lbl.pdf 11/19/2013
AP03/9/2015SCM       
AP08/21/2014SE840467006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s006lbl.pdf 9/9/2014
AP08/21/2014SE840468006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s006ltr.pdf 9/10/2014
AP04/30/2014SCM       
AP05/1/2015SCM       
AP08/12/2014SLR40219009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202155s009lbl.pdf 8/13/2014
AP08/12/2014SLR40225009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202155Orig1s009ltr.pdf 8/14/2014
AP06/16/2015SLR43071010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202155Orig1s010ltr.pdf 6/18/2015
AP06/16/2015SLR43085010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s010lbl.pdf 6/19/2015
AP09/10/2015SLR43850011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202155s011lbl.pdf 9/11/2015
AP09/10/2015SLR43856011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202155Orig1s011ltr.pdf 9/14/2015
AP07/20/2016SLR46581012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202155s012lbl.pdf 7/21/2016
AP07/20/2016SLR46593012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202155Orig1s012ltr.pdf 7/22/2016
AP05/3/2016SCM46730013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/202155Orig1s013.pdf 8/5/2016
AP03/2/2016S45372014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202155Orig1s014ltr.pdf 3/4/2016




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