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FDA Drug Application 021911 by EISAI INC

Application Number021911
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 Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/14/2008N21235000 11/17/2008
AP011/14/2008N21244000 11/18/2008
AP011/14/2008N21875000 2/19/2009
AP011/14/2008N21876000 2/19/2009
AP011/14/2008N23888000 11/16/2009
AP010/16/2009SLR24129004 11/24/2009
AP011/8/2010SLR26916005 11/8/2010
AP011/8/2010SLR26923005 11/10/2010
AP03/3/2011SLR28129007,021911s007lbl.pdf 3/7/2011
AP03/3/2011SLR28184007,021911s007ltr.pdf 3/8/2011
AP06/10/2011SLR29027008,201367s001ltr.pdf 6/3/2011
AP02/12/2015SLR41853012,201367Orig1s003ltr.pdf 2/17/2015
AP02/12/2015SLR41988012 3/3/2015
AP06/25/2015SLR43119013,201367Orig1s005ltr.pdf 6/26/2015
AP06/25/2015SLR43184013,201367s005lbl.pdf 7/1/2015

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