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FDA Drug Application 208471 by SANOFI-AVENTIS US

Application Number208471
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
AP07/27/2016N46662000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208471Orig1s000ltr.pdf 7/28/2016
AP07/27/2016N46664000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf 7/28/2016
AP07/27/2016N46990000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208471Orig1s000TOC.cfm 9/7/2016




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