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FDA Drug Application 050646 by GLAXOSMITHKLINE

Application Number050646
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
AP09/27/1990N       
AP09/9/1992SCP       
AP09/10/1992SCS       
AP08/9/1991SCM       
AP09/7/1994SLR       
AP010/20/1994SLR       
AP09/11/1996SLR       
AP08/20/1996SLR       
AP01/26/1998SLR       
AP06/20/1996SLR       
AP06/20/1996SLR       
AP012/24/1996SLR       
AP04/3/1997SCM       
AP011/25/1997SCS       
AP03/29/2002SLR1949014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf 3/29/2002
AP03/29/2002SLR1950014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/050646s014lbl.pdf 3/29/2002
AP02/23/2000SCM       
AP02/22/2002SCS       




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