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FDA Drug Application 018458 by SANOFI AVENTIS US

Application Number018458
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/23/1982N       
AP01/24/1984SLR       
AP06/26/1984SLR       
AP05/7/1985SLR       
AP010/25/1985SLR       
AP03/27/1987SLR       
AP05/22/1987SLR       
AP011/10/1988SLR       
AP03/2/1988SCM       
AP03/30/2000SCS       
AP010/31/2000SLR       
AP07/10/2003SLR6154012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18458slr012ltr.pdf 7/28/2003
AP08/7/2008SLR20583013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018458s013ltr.pdf 8/12/2008
AP03/10/2011SLR28152014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s014lbl.pdf 3/7/2011
AP03/10/2011SLR28154014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018458s014ltr.pdf 3/8/2011
AP06/22/2011SLR29301016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018458s016ltr.pdf 6/28/2011
AP06/22/2011SLR29346016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018458s016lbl.pdf 6/29/2011




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