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FDA Drug Application 125118 by BRISTOL MYERS SQUIBB

Application Number125118
Application Type Biologic License Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/2005N133120000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125118lbl.pdf 12/30/2005
AP012/23/2005N133570000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125118rev2.pdf 1/6/2006
AP012/23/2005N141160000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125118_s0000_OrenciaTOC.cfm 5/16/2006
AP03/13/2007S160090016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125118s0016lbl.pdf 3/13/2007
AP04/7/2008S199240045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125118s045ltr.pdf 6/3/2008
AP08/25/2009S232480086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf 8/27/2009
AP08/25/2009S232640086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125118s0086ltr.pdf 9/1/2009
AP07/29/2011S297360122   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125118s0122ltr.pdf 8/11/2011
AP02/17/2012SLR318490138   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125118s0138lbl.pdf 2/22/2012
AP02/17/2012SLR318710138   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125118s0138ltr.pdf 2/23/2012
AP06/23/2011SCM38307107   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/125118Orig1s107.pdf 1/17/2014
AP012/20/2013SE838133171   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125118s171lbl.pdf 12/23/2013
AP012/20/2013SE838159171   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125118Orig1s171ltr.pdf 12/24/2013
AP012/30/2014SLR41486179   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125118s179lbl.pdf 1/5/2015
AP012/30/2014SLR41514179   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125118Orig1s179ltr.pdf 1/7/2015
AP06/7/2016SE8       




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