Back to FDA Applications sponsored by BRISTOL MYERS SQUIBB

FDA Drug Application 125288 by BRISTOL MYERS SQUIBB

Application Number125288
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
AP06/15/2011N291880000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125288s0000lbl.pdf 6/16/2011
AP06/15/2011N292530000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125288s000ltr.pdf 6/24/2011
AP06/15/2011N293780000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM261711.pdf 7/1/2011
AP06/15/2011N297110000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125288Orig1s000TOC.cfm 8/8/2011
AP06/15/2011N299220000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=39 8/30/2011
AP04/8/2013SLR35645030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125288s030lbl.pdf 4/9/2013
AP04/8/2013SLR35670030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125288Orig1s030ltr.pdf 4/10/2013
AP04/14/2014SLR39048059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125288Orig1s059ltr.pdf 4/16/2014
AP04/14/2014SLR39051059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s059lbl.pdf 4/16/2014
AP09/30/2014SLR40691062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125288Orig1s062ltr.pdf 10/2/2014
AP09/30/2014SLR40697062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s062lbl.pdf 10/2/2014




Back to FDA Applications sponsored by BRISTOL MYERS SQUIBB