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FDA Drug Application 006002 by SANOFI AVENTIS US

Application Number006002
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/31/1949N       
AP01/29/1975SCS       
AP03/31/1976SLR       
AP04/12/1976SCS       
AP05/22/1978SCM       
AP01/8/1980SCP       
AP08/8/1980SCM       
AP05/15/1981SCP       
AP05/15/1981SCP       
AP010/14/1986SPD       
AP011/14/1986SPD       
AP05/14/1982SCS       
AP03/27/1987SLR       
AP06/18/1987SCM       
AP06/9/1989SLR       
AP07/13/1990SCM       
AP02/18/1993SLR       
AP05/17/1991SCS       
AP03/11/1992SCM       
AP06/23/1992SCF       
AP010/11/1995SCS       
AP05/9/2001SCS       
AP06/13/2003SLR5941039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06002slr039ltr.pdf 6/22/2003
AP06/13/2003SLR6005039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06002slr039_aralen_lbl.pdf 6/22/2003
AP04/30/2002SCS       
AP06/12/2009SLR22764042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/006002s042ltr.pdf 6/17/2009
AP011/6/2013SLR37737043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006002s043lbl.pdf 11/8/2013
AP011/6/2013SLR37740043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006002Orig1s043ltr.pdf 11/8/2013




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