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FDA Drug Application 203975 by GLAXOSMITHKLINE

Application Number203975
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
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
AP012/18/2013N38100000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203975s000lbl.pdf 12/19/2013
AP012/18/2013N38115000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203975Orig1s000ltr.pdf 12/20/2013
AP012/18/2013N38215000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203975Orig1s000TOC.cfm 1/6/2014
AP012/18/2013N38216000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203975Orig1s000SumR.pdf 1/6/2014
AP08/7/2015SCM       
AP08/27/2015SCM       
AP02/24/2016SLR45281003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203975Orig1s003ltr.pdf 2/26/2016
AP02/24/2016SLR45290003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203975s003lbl.pdf 2/26/2016




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