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FDA Drug Application 050627 by SANOFI AVENTIS US

Application Number050627
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/25/1989N       
AP06/18/1993SLR       
AP03/10/1992SLR       
AP09/17/1996SLR       
AP07/28/1995SCS       
AP04/12/2000SLR       
AP04/12/2000SLR       
AP08/20/2004SLR10029008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50420s072,50627s008ltr.pdf 8/25/2004
AP08/20/2004SLR10082008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf 8/25/2004
AP011/10/2010SLR26946012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf 11/12/2010
AP011/10/2010SLR26997012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012ltr.pdf 11/22/2010
AP02/27/2013SLR35290014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050420Orig1s075,050627Orig1s014ltr.pdf 3/1/2013
AP02/27/2013SLR35302014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf 3/1/2013
AP04/9/2015SCM       
AP012/2/2015SCM       




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