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FDA Drug Application 204275 by GLAXO GRP LTD

Application Number204275
Application Type New Drug Application
Sponsor ApplicantGLAXO GRP LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/10/2013N36043000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204275Orig1s000ltr.pdf 5/13/2013
AP05/10/2013N36048000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204275s000lbl.pdf 5/14/2013
AP05/10/2013N36070000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM352347.pdf 5/15/2013
AP05/10/2013N36246000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204275Orig1s000TOC.cfm 6/10/2013
AP04/30/2015SE842712001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s001ltr.pdf 5/4/2015
AP04/30/2015SE842727001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s001lbl.pdf 5/4/2015
AP03/2/2015SLR41986002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s002ltr.pdf 3/3/2015
AP03/2/2015SLR42030002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s002lbl.pdf 3/5/2015
AP09/15/2015SLR43882004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s004ltr.pdf 9/16/2015
AP09/15/2015SLR43968004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s004lbl.pdf 9/23/2015
AP08/11/2015SCM       
AP010/21/2015SCM       
AP02/16/2016SLR45181009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204275Orig1s009ltr.pdf 2/18/2016
AP02/16/2016SLR45197009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s009lbl.pdf 2/18/2016




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