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FDA Drug Application 050591 by GLAXOSMITHKLINE

Application Number050591
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
AP012/31/1987N       
AP04/15/1991SLR       
AP04/15/1991SLR       
AP04/15/1991SLR       
AP09/30/1991SLR       
AP04/15/1991SLR       
AP02/21/1996SLR       
AP03/24/1994SCM       
AP03/24/1994SCP       
AP011/2/1993SCE       
AP06/6/1996SCS       
AP012/24/1996SCM       
AP012/3/1997SCM       
AP04/22/1999SE83787022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50591s22ltr.pdf 4/22/1999
AP04/22/1999SE83791022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50591S022_Bactroban.pdf 7/12/2002
AP05/19/1999SCS       
AP09/12/2000SCP       
AP09/21/2001SCS       
AP011/9/2001SCS       
AP03/19/2015SLR42229030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s030lbl.pdf 3/20/2015
AP03/19/2015SLR42231030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050591Orig1s030ltr.pdf 3/20/2015
AP05/22/2014SLR39359032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Orig1s015,50746Orig1s018ltr.pdf 5/27/2014
AP05/22/2014SLR39390032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050591s032,050703s015,050746s018lbl.pdf 5/28/2014
AP012/14/2015SLR44772033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050591s033lbl.pdf 12/15/2015




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