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FDA Drug Application 050746 by GLAXOSMITHKLINE

Application Number050746
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/11/1997N6458000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050746_bactroban_toc.cfm 8/8/2003
AP06/10/1998SCP       
AP09/4/1998SCM       
AP05/19/1999SCS       
AP010/6/1999SCM       
AP07/14/2000SCM       
AP012/13/2000SCM       
AP09/21/2001SCS       
AP011/9/2001SCS       
AP011/15/2001SCS       
AP03/19/2015SLR42221013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050746Orig1s013ltr.pdf 3/20/2015
AP03/19/2015SLR42228013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s013lbl.pdf 3/20/2015
AP05/22/2014SLR39361018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Orig1s015,50746Orig1s018ltr.pdf 5/27/2014
AP05/22/2014SLR39388018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf 5/28/2014
AP012/16/2015SCM       
AP012/14/2015SLR44770020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050746Orig1s020ltr.pdf 12/15/2015
AP012/14/2015SLR44771020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050746s020lbl.pdf 12/15/2015




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