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FDA Drug Application 206538 by SANOFI US SERVICES

Application Number206538
Application Type New Drug Application
Sponsor ApplicantSANOFI US SERVICES
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/25/2015N41930000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538s000lbl.pdf 2/27/2015
AP02/25/2015N41944000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206538Orig1s000ltr.pdf 2/27/2015
AP02/25/2015N45311000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206538Orig1s000TOC.cfm 3/2/2016
AP02/25/2015N45312000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206538Orig1s000SumR.pdf 3/2/2016
AP02/16/2016SCM       




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