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FDA Drug Application 017920 by GLAXOSMITHKLINE

Application Number017920
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/16/1977N       
AP03/17/1978SLR       
AP011/30/1977SLR       
AP011/30/1977SLR       
AP03/16/1978SCE       
AP04/23/1980SES       
AP09/28/1978SCM       
AP09/28/1978SLR       
AP011/30/1978SLR       
AP011/30/1978SLR       
AP02/28/1979SCS       
AP02/1/1979SLR       
AP04/23/1980SES       
AP01/8/1980SCS       
AP06/29/1979SLR       
AP01/7/1980SCP       
AP08/28/1981SCE       
AP04/23/1980SLR       
AP07/8/1980SLR       
AP07/8/1980SLR       
AP07/8/1980SLR       
AP06/2/1981SCF       
AP012/30/1982SES       
AP01/22/1981SLR       
AP01/22/1981SLR       
AP012/30/1982SLR       
AP07/13/1981SLR       
AP011/2/1981SLR       
AP01/22/1982SLR       
AP08/25/1982SES       
AP01/4/1983SCS       
AP012/27/1984SES       
AP01/31/1983SES       
AP02/28/1983SLR       
AP012/14/1983SES       
AP07/19/1984SLR       
AP09/23/1983SCM       
AP03/5/1984SLR       
AP03/22/1984SLR       
AP07/19/1984SLR       
AP06/18/1984SLR       
AP09/26/1984SCP       
AP04/29/1986SE2       
AP02/7/1985SLR       
AP04/18/1985SLR       
AP04/30/1986SCS       
AP012/18/1985SCM       
AP01/13/1986SLR       
AP04/23/1986SLR       
AP04/29/1986SE1       
AP03/31/1988SE2       
AP05/20/1988SLR       
AP06/15/1988SLR       
AP06/26/1989SLR       
AP06/26/1989SLR       
AP03/7/1991SE1       
AP05/30/1990SCS       
AP011/13/1989SLR       
AP011/13/1991SLR       
AP08/27/1992SCS       
AP01/7/1992SLR       
AP07/16/1992SCS       
AP06/8/1993SCM       
AP09/29/1993SCS       
AP011/10/1993SCM       
AP02/22/1995SLR       
AP01/19/1996SCS       
AP07/16/1996SCM       
AP04/15/1997SCS       
AP07/14/1998SCP       
AP07/29/1998SCS       
AP012/14/2005SLR13292094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017920s094ltr.pdf 12/16/2005
AP07/12/2006SLR14503095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017920s095_ltr.pdf 7/21/2006




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