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FDA Drug Application 018584 by GLAXOSMITHKLINE

Application Number018584
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/30/1981N       
AP02/16/1988SCS       
AP02/16/1988SLR       
AP02/24/1988SLR       
AP03/1/1984SCF       
AP03/1/1984SCP       
AP09/15/1984SCS       
AP011/1/1985SLR       
AP011/1/1985SE1       
AP010/4/1985SCP       
AP010/4/1985SLR       
AP03/6/1987SCM       
AP012/2/1987SCP       
AP04/27/1989SCM       
AP012/15/1988SLR       
AP011/19/1993SLR       
AP08/10/1992SCM       
AP07/6/1993SCP       
AP03/12/1996SLR       
AP04/4/1996SLR       
AP012/16/2002SLR4433026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18584slr026ltr.pdf 12/16/2002
AP08/31/2001SLR5225027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18584s27lbl.pdf 4/14/2003
AP02/20/2002SCE       




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