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FDA Drug Application 202992 by SANOFI AVENTIS US

Application Number202992
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
AP09/12/2012N33752000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202992Orig1s000ltr.pdf 9/14/2012
AP09/12/2012N33758000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202992s000lbl.pdf 9/14/2012
AP09/12/2012N33910000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322204.pdf 10/2/2012
AP09/12/2012N34248000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202992Orig1s000TOC.cfm 11/5/2012
AP09/12/2012N34249000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202992Orig1s000SumR.pdf 11/5/2012
AP010/17/2014SE840846001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202992s001lbl.pdf 10/21/2014
AP010/17/2014SE840854001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202992Orig1s001ltr.pdf 10/22/2014
AP06/2/2016SLR46255003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202992Orig1s003ltr.pdf 6/6/2016
AP06/2/2016SLR46259003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s003lbl.pdf 6/6/2016




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