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FDA Drug Application 125431 by GLAXOSMITHKLINE LLC

Application Number125431
Application Type Biologic License Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
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
AP04/15/2014N39057000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125431Orig1s000ltr.pdf 4/16/2014
AP04/15/2014N39088000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125431s000lbl.pdf 4/17/2014
AP04/15/2014N39103000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=316 4/18/2014
AP04/15/2014N39299000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000TOC.cfm 5/13/2014
AP04/15/2014N39300000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000SumR.pdf 5/13/2014
AP03/9/2015SLR42084008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s008ltr.pdf 3/11/2015
AP05/7/2015SLR42757009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125431s009lbl.pdf 5/8/2015
AP05/7/2015SLR42769009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s009ltr.pdf 5/11/2015
AP05/7/2015SLR42919009   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM448173.pdf 5/27/2015
AP07/27/2015SE843508014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s014ltr.pdf 7/28/2015
AP09/13/2016SLR47044018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125431Orig1s018ltr.pdf 9/15/2016
AP09/13/2016SLR47062018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125431s018lbl.pdf 9/15/2016




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