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FDA Drug Application 021986 by BRISTOL MYERS SQUIBB

Application Number021986
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/28/2006N14390000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021986lbl.pdf 7/3/2006
AP06/28/2006N14405000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021986s000ltr.pdf 7/3/2006
AP06/28/2006N14787000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021986_022072_SprycelTOC.cfm 9/6/2006
AP011/8/2007SE230061001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf 9/22/2011
AP011/8/2007SE218450001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf 11/19/2007
AP011/8/2007SE830062002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf 9/22/2011
AP011/8/2007SE818414002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021986s001s002lbl.pdf 11/13/2007
AP011/8/2007SE818449002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf 11/19/2007
AP05/30/2008SCS19918003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021986s003,022072s001ltr.pdf 6/3/2008
AP05/21/2009SE222604004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021986s004lbl.pdf 5/25/2009
AP05/21/2009SE222653004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021986s004ltr.pdf 5/29/2009
AP07/28/2010SLR26068005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s005lbl.pdf 7/31/2010
AP07/28/2010SLR26122005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022072s002,021986s005ltr.pdf 8/9/2010
AP010/28/2010SE826819007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf 10/28/2010
AP010/28/2010SE826876007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s007ltr.pdf 11/3/2010
AP010/28/2010SE126877008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s008ltr.pdf 11/3/2010
AP010/28/2010SE126821008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf 10/28/2010
AP010/7/2011SLR30260009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf 10/12/2011
AP010/7/2011SLR30296009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf 10/13/2011
AP010/7/2011SLR30297010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf 10/13/2011
AP010/7/2011SLR30261010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf 10/12/2011
AP06/17/2013SLR36295013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021986s013lbl.pdf 6/17/2013
AP06/17/2013SLR36335013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021986Orig1s013ltr.pdf 6/18/2013
AP04/10/2014SLR39035014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021986Orig1s014ltr.pdf 4/14/2014
AP04/10/2014SLR39295014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021986s014lbl.pdf 5/12/2014
AP01/26/2015SCM       
AP08/12/2015SE843651016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf 8/14/2015
AP08/12/2015SE843643016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf 8/13/2015
AP08/12/2015SLR43644017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf 8/13/2015
AP08/12/2015SLR43652017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf 8/14/2015
AP09/27/2016SLR47211018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021986s018lbl.pdf 9/29/2016
AP09/27/2016SLR47240018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021986Orig1s018ltr.pdf 9/30/2016




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