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FDA Drug Application 205625 by GLAXOSMITHKLINE

Application Number205625
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/20/2014N40300000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205625Orig1s000ltr.pdf 8/21/2014
AP08/20/2014N40302000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205625s000lbl.pdf 8/22/2014
AP08/20/2014N44145000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205625Orig1s000TOC.cfm 10/7/2015
AP08/20/2014N44146000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205625Orig1s000SumR.pdf 10/7/2015
AP03/20/2015SLR42242001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205625Orig1s001ltr.pdf 3/24/2015
AP03/20/2015SLR42261001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205625Orig1s001Lbl.pdf 3/24/2015




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