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FDA Drug Application 125377 by BRISTOL MYERS SQUIBB

Application Number125377
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/25/2011N28355000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf 3/25/2011
AP13/25/2011N28355000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf 3/25/2011
AP03/25/2011N28356000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249168.pdf 3/25/2011
AP13/25/2011N28356000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249168.pdf 3/25/2011
AP03/25/2011N28401000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125377s000ltr.pdf 3/29/2011
AP13/25/2011N28401000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125377s000ltr.pdf 3/29/2011
AP03/25/2011N28804000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000TOC.cfm 5/16/2011
AP13/25/2011N28804000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000TOC.cfm 5/16/2011
AP03/25/2011N29056000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000SumR.pdf 6/8/2011
AP13/25/2011N29056000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000SumR.pdf 6/8/2011
AP02/16/2012SLR31865016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377s016ltr.pdf 2/23/2012
AP010/26/2012SLR34204033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377Orig1s033ltr.pdf 10/30/2012
AP010/26/2012SLR34205033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125377s033lbl.pdf 10/30/2012
AP05/22/2013SLR36130044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s044lbl.pdf 5/23/2013
AP05/22/2013SLR36146044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s044ltr.pdf 5/28/2013
AP012/5/2013SLR37979055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s055lbl.pdf 12/6/2013
AP012/5/2013SLR37985055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s055ltr.pdf 12/9/2013
AP03/19/2015SLR42232072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s072ltr.pdf 3/20/2015
AP03/19/2015SLR42250072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s072lbl.pdf 3/24/2015
AP010/28/2015SES44340073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s073ltr.pdf 10/30/2015
AP010/28/2015SES45696073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf 4/19/2016
AP08/17/2015S43664074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf 8/18/2015
AP08/17/2015S43672074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s074ltr.pdf 8/19/2015




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