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FDA Drug Application 019508 by SMITHKLINE BEECHAM

Application Number019508
Application Type New Drug Application
Sponsor ApplicantSMITHKLINE BEECHAM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/12/1988N       
AP06/20/1988SLR       
AP02/6/1996SCM       
AP02/23/1989SLR       
AP03/16/1989SLR       
AP08/29/1990SCS       
AP04/21/1989SLR       
AP06/9/1992SCM       
AP08/29/1990SCS       
AP07/26/1991SE1       
AP04/10/1990SLR       
AP04/11/1991SLR       
AP011/25/1991SLR       
AP09/21/1993SE1       
AP011/25/1991SLR       
AP05/13/1993SLR       
AP05/13/1993SCP       
AP08/31/1995SCP       
AP02/2/1995SLR       
AP07/23/1996SCF       
AP010/8/1996SCP       
AP010/13/1998SCS       
AP05/22/1996SCS       
AP01/19/1999SCP       
AP06/19/1998SCM       
AP03/2/2001SLR1592030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19508S30LTR.PDF 3/2/2001
AP012/23/2005SCM13327033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019508s033lbl.pdf 1/5/2006
AP012/23/2005SCM13366033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019508s033rev2.pdf 1/6/2006
AP01/24/2006SCM13532034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019508s034ltr.pdf 1/30/2006




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