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FDA Drug Application 050703 by GLAXOSMITHKLINE

Application Number050703
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/18/1995N       
AP011/20/1995SCM       
AP04/3/1996SCS       
AP09/4/1998SCM       
AP05/19/1999SCS       
AP010/6/1999SCM       
AP012/13/2000SCM       
AP011/9/2001SCS       
AP011/15/2001SCS       
AP05/22/2014SLR39360015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Orig1s015,50746Orig1s018ltr.pdf 5/27/2014
AP05/22/2014SLR39389015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf 5/28/2014
AP05/14/2015SLR42835016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050703Orig1s016ltr.pdf 5/19/2015
AP05/14/2015SLR42871016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050703s016lbl.pdf 5/21/2015




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