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FDA Drug Application 019436 by SANOFI AVENTIS US

Application Number019436
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
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
AP012/31/1987N       
AP07/14/1989SCM       
AP07/9/1991SCM       
AP03/20/1992SLR       
AP03/1/1994SCP       
AP09/6/1995SCS       
AP010/6/1995SLR       
AP06/7/1995SCS       
AP08/15/1996SCS       
AP03/16/1998SCP       
AP07/6/1999SLR       
AP011/29/2000SLR       
AP02/6/2001SCM       
AP010/18/2001SCS       
AP010/30/2002SCM       
AP09/16/2002SCS       
AP04/18/2003SLR5370019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19436slr019,20343slr014ltr.pdf 4/18/2003
AP05/1/2007SLR16435021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s021_020343s020ltr.pdf 5/7/2007
AP010/30/2007SLR18377022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s022, 020343s021ltr.pdf 11/8/2007




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