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FDA Drug Application 016042 by GLAXOSMITHKLINE LLC

Application Number016042
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/2/1965N       
AP06/23/1976SOA       
AP01/27/1976SOA       
AP02/27/1975SCP       
AP02/27/1975SLR       
AP06/23/1976SLR       
AP06/12/1975SLR       
AP01/27/1976SCF       
AP05/21/1976SLR       
AP05/21/1976SLR       
AP011/3/1976SLR       
AP04/12/1977SLR       
AP02/14/1977SCP       
AP02/14/1977SCP       
AP06/14/1977SCF       
AP02/22/1978SLR       
AP02/22/1978SLR       
AP02/22/1978SLR       
AP02/22/1978SLR       
AP01/19/1978SCM       
AP01/19/1978SCP       
AP01/19/1978SCS       
AP09/18/1979SLR       
AP09/18/1979SLR       
AP09/18/1979SLR       
AP02/2/1981SCF       
AP012/6/1979SLR       
AP01/14/1980SLR       
AP01/27/1981SLR       
AP07/14/1980SLR       
AP02/23/1982SLR       
AP04/26/1988SPD       
AP010/30/1981SLR       
AP08/25/1982SLR       
AP010/8/1982SLR       
AP01/3/1985SLR       
AP05/13/1983SCM       
AP03/3/1994SE1       
AP03/7/1985SLR       
AP07/29/1986SLR       
AP02/23/1988SCS       
AP012/2/1991SCF       
AP05/1/1992SCS       
AP03/3/1994SLR       
AP05/20/1994SCS       
AP012/1/1994SLR       
AP08/31/1998SCM       
AP03/16/1999SCM       
AP02/23/2001SLR       
AP012/20/2000SCM       
AP05/18/2007SLR16609074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016042s074ltr.pdf 5/29/2007
AP02/23/2010SLR24861077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016042s077ltr.pdf 2/26/2010
AP02/23/2010SLR24928077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016042s077lbl.pdf 3/3/2010
AP03/15/2011SLR28267078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016042s078ltr.pdf 3/17/2011
AP03/15/2011SLR28291078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016042s078lbl.pdf 3/21/2011




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