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FDA Drug Application 021798 by BRISTOL MYERS SQUIBB

Application Number021798
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
AP03/29/2005N11335000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021797,021798lbl.pdf 3/31/2005
AP03/29/2005N11340000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021797,021798ltr.pdf 3/31/2005
AP03/29/2005N13226000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21797_21798_BaracludeTOC.cfm 12/6/2005
AP02/23/2007SE815909001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s001,021798s001lbl.pdf 2/26/2007
AP02/23/2007SE815960001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s001,021798s001ltr.pdf 3/6/2007
AP03/27/2007SE216113002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s002, 021798s002ltr.pdf 3/31/2007
AP03/27/2007SE216128002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s002,021798s002lbl.pdf 3/31/2007
AP07/24/2007SLR17385003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s003,021798s003lbl.pdf 7/27/2007
AP07/24/2007SLR17391003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s003, 021798s003ltr.pdf 7/27/2007
AP07/25/2008SE820344006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s005, 021798s006ltr.pdf 7/31/2008
AP07/25/2008SE820595006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021797s005,021798s006lbl.pdf 8/13/2008
AP06/3/2008SLR19965007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s006, 021798s007ltr.pdf 6/6/2008
AP07/16/2009SE823011008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s008,021798s008ltr.pdf 7/22/2009
AP07/16/2009SE823065008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s008, 021798s008lbl.pdf 7/24/2009
AP02/25/2009SLR21923010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s009,021798s010ltr.pdf 2/27/2009
AP02/25/2009SLR22023010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s009,021798s010lbl.pdf 3/17/2009
AP010/15/2010SE826823011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s010,021798s011lbl.pdf 10/29/2010
AP012/28/2010SLR27438012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021798s012lbl.pdf 12/28/2010
AP012/28/2010SLR27445012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021797s011,021798s012ltr.pdf 1/4/2011
AP010/12/2012SE534092014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf 10/15/2012
AP010/12/2012SE534101014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf 10/15/2012
AP010/12/2012SE534093016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf 10/15/2012
AP010/12/2012SE534102016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf 10/15/2012
AP06/18/2013SCM       
AP012/18/2013SLR38130018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021797Orig1s017,021798Orig1s018ltr.pdf 12/20/2013
AP012/18/2013SLR38150018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.pdf 12/23/2013
AP03/20/2014SE838867019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021797Orig1s18,021798Orig1s19ltr.pdf 3/21/2014
AP03/20/2014SE838884019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021797s018,021798s019lbl.pdf 3/25/2014




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