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FDA Drug Application 050461 by GLAXOSMITHKLINE

Application Number050461
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/4/1973N       
AP02/14/1990SCS       
AP01/28/1992SCS       
AP03/12/1992SCE       
AP06/28/1991SCS       
AP06/22/1992SCS       
AP01/23/1974SLR       
AP03/15/1974SCS       
AP010/3/1974SLR       
AP06/26/1974SCS       
AP09/26/1974SCM       
AP09/26/1974SLR       
AP012/24/1974SLR       
AP02/18/1975SLR       
AP02/25/1975SLR       
AP04/10/1975SLR       
AP04/10/1975SLR       
AP04/29/1975SLR       
AP05/12/1975SLR       
AP07/7/1975SLR       
AP06/8/1977SLR       
AP09/10/1975SLR       
AP09/18/1975SCS       
AP011/20/1975SCS       
AP011/20/1975SCS       
AP02/26/1976SLR       
AP02/26/1976SLR       
AP03/1/1976SCS       
AP03/15/1976SCP       
AP03/15/1976SCP       
AP05/6/1976SCP       
AP05/10/1976SCS       
AP06/8/1976SLR       
AP06/16/1976SLR       
AP07/8/1976SCS       
AP08/5/1976SLR       
AP08/12/1976SLR       
AP010/8/1976SLR       
AP05/22/1978SLR       
AP06/9/1977SLR       
AP010/14/1977SLR       
AP012/15/1977SLR       
AP04/6/1978SCS       
AP05/23/1978SCS       
AP05/23/1978SLR       
AP07/25/1978SLR       
AP08/10/1978SLR       
AP08/17/1978SLR       
AP08/22/1978SLR       
AP08/28/1978SLR       
AP09/29/1978SLR       
AP010/18/1978SLR       
AP011/14/1978SLR       
AP011/28/1978SCS       
AP02/23/1979SCE       
AP05/15/1979SCS       
AP02/26/1980SLR       
AP03/5/1980SCS       
AP07/17/1980SLR       
AP01/27/1981SLR       
AP02/11/1981SLR       
AP03/12/1981SLR       
AP06/19/1981SLR       
AP04/8/1981SLR       
AP06/10/1981SLR       
AP07/23/1981SLR       
AP08/11/1981SLR       
AP09/1/1981SLR       
AP09/3/1981SLR       
AP011/27/1981SCS       
AP01/4/1982SLR       
AP02/19/1982SLR       
AP03/8/1982SLR       
AP04/20/1982SLR       
AP05/5/1982SLR       
AP05/12/1982SLR       
AP05/18/1982SLR       
AP06/4/1982SLR       
AP06/28/1982SLR       
AP07/12/1982SLR       
AP07/12/1982SLR       
AP09/20/1982SLR       
AP05/29/1992SCM       
AP07/14/1992SLR       
AP01/4/1994SCM       
AP07/29/1999SLR       
AP05/21/2002SCS       
AP01/15/2004SLR7595135   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50461slr135ltr.pdf 1/22/2004
AP01/15/2004SLR7617135   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr135_ancef_lbl.pdf 1/22/2004
AP01/6/2005SLR10927138   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50461s138ltr.pdf 1/11/2005
AP06/2/2004SLR9082139   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50461slr139ltr.pdf 6/7/2004
AP06/2/2004SLR9132139   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr139_ancef_lbl.pdf 6/7/2004




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