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FDA Drug Application 125418 by SANOFI AVENTIS US

Application Number125418
Application Type Biologic License Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/3/2012N33363000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125418s000lbl.pdf 8/3/2012
AP08/3/2012N33364000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125418Orig1s000ltr.pdf 8/3/2012
AP08/3/2012N33656000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418_zaltrap_toc.cfm 9/6/2012
AP08/3/2012N33657000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418Orig1s000SumR.pdf 9/6/2012
AP010/25/2013SLR37591020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125418Orig1s020ltr.pdf 10/28/2013
AP010/25/2013SLR37647020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125418s020lbl.pdf 10/31/2013
AP09/17/2015SE843917033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125418Orig1s033ltr.pdf 9/18/2015
AP03/9/2016SLR45415037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125418Orig1s037ltr.pdf 3/11/2016
AP03/9/2016SLR45435037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s037lbl.pdf 3/14/2016
AP06/24/2016SLR46425039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125418s039lbl.pdf 6/27/2016
AP06/24/2016SLR46430039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125418Orig1s039ltr.pdf 6/27/2016




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