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FDA Drug Application 019389 by GLAXOSMITHKLINE

Application Number019389
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
AP07/27/1987N       
AP08/19/1988SCE       
AP08/25/1989SCS       
AP07/8/1988SCM       
AP012/19/1988SLR       
AP03/9/1989SCM       
AP09/7/1989SCP       
AP05/15/1990SCM       
AP010/6/1992SCS       
AP08/10/1992SCM       
AP011/19/1993SLR       
AP011/26/1996SLR       
AP05/30/1997SLR       
AP03/27/1998SCM       
AP02/24/1999SCM       
AP012/19/2002SLR4431021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19389slr021ltr.pdf 12/19/2002
AP08/31/2001SLR5271023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19389s23lbl.pdf 4/15/2003
AP07/9/2001SCS       
AP012/16/2002SLR4432025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19389slr025ltr.pdf 12/16/2002
AP03/4/2002SCS       
AP010/27/2005SLR12987027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019389s027lbl.pdf 11/1/2005
AP010/27/2005SLR13009027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019389s027ltr.pdf 11/1/2005
AP06/17/2014SCM       




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