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FDA Drug Application 205382 by GLAXO GRP ENGLAND

Application Number205382
Application Type New Drug Application
Sponsor ApplicantGLAXO GRP ENGLAND
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
AP04/30/2014N39188000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205382Orig1s000ltr.pdf 5/1/2014
AP04/30/2014N39204000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205382s000lbl.pdf 5/2/2014
AP04/30/2014N43622000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205382Orig1s000TOC.cfm 8/11/2015
AP04/30/2014N43623000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205382Orig1s000SumR.pdf 8/11/2015
AP02/24/2016SE845280002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205382Orig1s002ltr.pdf 2/26/2016
AP02/24/2016SE845289002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205382s002lbl.pdf 2/26/2016




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