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FDA Drug Application 018538 by SANOFI AVENTIS US

Application Number018538
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
AP07/6/1983N       
AP011/29/1983SCS       
AP010/12/1983SCP       
AP04/10/1984SCM       
AP06/30/1987SCS       
AP07/8/1988SCE       
AP011/9/1988SLR       
AP011/29/1988SCS       
AP02/23/1989SCS       
AP01/3/1990SCS       
AP07/10/1989SCP       
AP010/13/1989SCF       
AP03/8/1990SCF       
AP06/23/1992SCM       
AP09/25/1991SLR       
AP04/1/1992SCM       
AP06/24/1992SLR       
AP04/29/1993SE2       
AP08/19/1993SCS       
AP03/31/1993SLR       
AP010/29/1996SLR       
AP010/29/1996SLR       
AP05/16/1996SCM       
AP02/26/1996SCS       
AP01/27/1998SCS       
AP012/11/1998SCM       
AP010/10/2000SLR       
AP03/7/2000SCM       
AP09/3/2009SLR23554028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018538s028lbl.pdf 10/8/2009
AP09/3/2009SLR23751028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018538s028ltr.pdf 11/9/2009




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