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FDA Drug Application 206947 by EISAI INC

Application Number206947
Application Type New Drug Application
Sponsor ApplicantEISAI INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/13/2015N41842000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf 2/13/2015
AP02/13/2015N41848000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206947Orig1s000ltr.pdf 2/17/2015
AP02/13/2015N42115000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206947Orig1s000TOC.cfm 3/12/2015
AP02/13/2015N42116000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206947Orig1s000SumR.pdf 3/12/2015
AP010/16/2015SCM       
AP05/13/2016SE846021003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s003lbl.pdf 5/13/2016
AP05/13/2016SE846024003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s003ltr.pdf 5/16/2016
AP04/22/2016SLR45741004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s004ltr.pdf 4/26/2016
AP04/22/2016SLR45799004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s004lbl.pdf 4/29/2016




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