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FDA Drug Application 050705 by SANOFI AVENTIS US

Application Number050705
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/31/1994N       
AP07/8/1994SLR       
AP04/8/1996SCS       
AP04/12/2000SLR       
AP010/6/2000SCM       
AP04/28/2005SLR11554005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050705s005ltr.pdf 5/2/2005
AP04/28/2005SLR11560005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050705s005lbl.pdf 5/2/2005
AP012/18/2008SLR21421006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050705s006ltr.pdf 12/29/2008
AP012/18/2008SLR21453006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050705s006lbl.pdf 1/2/2009
AP011/12/2010SLR26964007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050705s007lbl.pdf 11/17/2010
AP011/12/2010SLR26998007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050705s007ltr.pdf 11/22/2010
AP02/27/2013SLR35294010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050705Orig1s010ltr.pdf 3/1/2013
AP02/27/2013SLR35301010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050705s010lbl.pdf 3/1/2013




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