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FDA Drug Application 019583 by SMITHKLINE BEECHAM

Application Number019583
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
AP012/24/1991N       
AP01/25/1993SCM       
AP011/23/1993SLR       
AP011/23/1993SLR       
AP09/22/1994SCS       
AP010/26/1994SCM       
AP01/4/1995SCS       
AP05/10/1995SCS       
AP07/14/1995SCS       
AP06/18/1996SCS       
AP07/24/1996SCM       
AP02/3/1998SCM       
AP08/2/1999SCM       
AP010/11/2001SLR       
AP06/14/2001SCS       
AP08/11/2005SLR12596023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019583s023ltr.pdf 8/15/2005
AP08/11/2005SLR12597023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019583s023lbl.pdf 8/15/2005
AP01/24/2006SLR13484025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019583s025lbl.pdf 1/25/2006
AP01/24/2006SLR13533025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019583s025ltr.pdf 1/30/2006




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