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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   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf 3/7/2011
AP03/3/2011N28174000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088564.pdf 3/8/2011
AP03/3/2011N28183000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201367s000,021911s007ltr.pdf 3/8/2011
AP03/3/2011N29399000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201367_banzel_toc.cfm 7/6/2011
AP03/3/2011N29400000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201367Orig1s000SumR.pdf 7/6/2011
AP06/10/2011SLR29028001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021911s008,201367s001ltr.pdf 6/3/2011
AP01/5/2015SCM       
AP02/12/2015SE841854003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s012,201367Orig1s003ltr.pdf 2/17/2015
AP02/12/2015SE841989003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s012lbl.pdf 3/3/2015
AP06/25/2015SLR43120005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s013,201367Orig1s005ltr.pdf 6/26/2015
AP06/25/2015SLR43183005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.pdf 7/1/2015
AP010/6/2015SCM       




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