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FDA Drug Application 201367 by EISAI INC

Application Number201367
Application Type New Drug Application
Sponsor ApplicantEISAI INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan CodeV

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/3/2011N28130000,021911s007lbl.pdf 3/7/2011
AP03/3/2011N28174000 3/8/2011
AP03/3/2011N28183000,021911s007ltr.pdf 3/8/2011
AP03/3/2011N29399000 7/6/2011
AP03/3/2011N29400000 7/6/2011
AP06/10/2011SLR29028001,201367s001ltr.pdf 6/3/2011
AP02/12/2015SE841854003,201367Orig1s003ltr.pdf 2/17/2015
AP02/12/2015SE841989003 3/3/2015
AP06/25/2015SLR43120005,201367Orig1s005ltr.pdf 6/26/2015
AP06/25/2015SLR43183005,201367s005lbl.pdf 7/1/2015

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