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FDA Drug Application 103767 by EISAI INC

Application Number103767
Application Type Biologic License Application
Sponsor ApplicantEISAI INC
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
AP02/5/1999N80550000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080717.htm 3/25/2004
AP02/5/1999N80560000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/denser020599L.htm 3/25/2004
AP02/5/1999N80570000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/denser020599lb.pdf 3/25/2004
AP010/16/2008S210615094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103767s5094ltr.pdf 10/23/2008
AP010/16/2008S210945094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103767s5094lbl.pdf 10/28/2008
AP08/30/2011S299435119   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103767s5119lbl.pdf 9/2/2011




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