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FDA Drug Application 019546 by SMITHKLINE BEECHAM

Application Number019546
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
AP012/20/1990N3735000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-546_Isradipine.cfm 9/10/2002
AP04/30/1991SCP       
AP06/13/1991SLR       
AP06/12/1991SCF       
AP06/13/1991SLR       
AP08/5/1991SCP       
AP011/6/1991SCS       
AP011/6/1991SCS       
AP08/17/1992SCP       
AP02/8/1993SCS       
AP03/23/1993SCP       
AP011/3/1993SLR       
AP05/4/1995SLR       
AP04/4/1995SCS       
AP011/2/1995SCM       
AP011/27/1995SCS       
AP01/14/1997SCM       
AP04/28/1999SCP       
AP05/7/1999SCM       
AP012/14/1999SCS       
AP05/30/2001SCS       
AP04/29/2002SCM       
AP06/14/2002SCM       
AP05/18/2005SLR11664031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019546s031,020336s013ltr.pdf 5/20/2005




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