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FDA Drug Application 019058 by ASTRAZENECA

Application Number019058
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/13/1989N       
AP04/5/1991SLR       
AP04/5/1991SLR       
AP04/17/1991SLR       
AP09/18/1991SLR       
AP08/5/1992SLR       
AP08/5/1992SLR       
AP04/29/1993SLR       
AP05/4/1994SLR       
AP03/20/1996SLR       
AP02/5/1998SCM       
AP04/4/2000SLR3836012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf 6/4/2001
AP07/21/1999SLR3833013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf 6/4/2001
AP010/19/2001SCM       
AP01/22/2003SLR3930015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19058slr015ltr.pdf 1/22/2003
AP011/6/2003SLR6901016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr028,19058slr016ltr.pdf 11/13/2003
AP02/9/2005SLR11100017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19058s017ltr.pdf 2/11/2005




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