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FDA Drug Application 021797 by BRISTOL MYERS SQUIBB

Application Number021797
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
AP03/29/2005N11334000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021797,021798lbl.pdf 3/31/2005
AP03/29/2005N11339000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021797,021798ltr.pdf 3/31/2005
AP03/29/2005N11977000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21797_21798_BaracludeTOC.cfm 7/12/2005
AP02/23/2007SE115910001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s001,021798s001lbl.pdf 2/26/2007
AP02/23/2007SE115961001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s001,021798s001ltr.pdf 3/6/2007
AP03/27/2007SE216114002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s002, 021798s002ltr.pdf 3/31/2007
AP03/27/2007SE216129002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s002,021798s002lbl.pdf 3/31/2007
AP07/24/2007SLR17384003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s003,021798s003lbl.pdf 7/27/2007
AP07/24/2007SLR17390003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s003, 021798s003ltr.pdf 7/27/2007
AP07/25/2008SE820343005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s005, 021798s006ltr.pdf 7/31/2008
AP07/25/2008SE820594005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021797s005,021798s006lbl.pdf 8/13/2008
AP06/3/2008SLR19964006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s006, 021798s007ltr.pdf 6/6/2008
AP07/16/2009SE823010008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s008,021798s008ltr.pdf 7/22/2009
AP07/16/2009SE823066008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s008, 021798s008lbl.pdf 7/24/2009
AP02/25/2009SLR21922009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s009,021798s010ltr.pdf 2/27/2009
AP02/25/2009SLR22022009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s009,021798s010lbl.pdf 3/17/2009
AP010/15/2010SE826822010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s010,021798s011lbl.pdf 10/29/2010
AP012/28/2010SLR27439011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s011lbl.pdf 12/28/2010
AP012/28/2010SLR27444011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021797s011,021798s012ltr.pdf 1/4/2011
AP010/12/2012SE534090013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf 10/15/2012
AP010/12/2012SE534103013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf 10/15/2012
AP010/12/2012SE534104014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf 10/15/2012
AP010/12/2012SE534091014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf 10/15/2012
AP04/16/2013SCM       
AP06/18/2013SCM       
AP012/19/2013SLR38129017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021797Orig1s017,021798Orig1s018ltr.pdf 12/20/2013
AP012/19/2013SLR38151017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.pdf 12/23/2013
AP03/20/2014SE838866018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021797Orig1s18,021798Orig1s19ltr.pdf 3/21/2014
AP03/20/2014SE838885018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021797s018,021798s019lbl.pdf 3/25/2014




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