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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   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021911lbl.pdf 11/17/2008
AP011/14/2008N21244000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021911s000ltr.pdf 11/18/2008
AP011/14/2008N21875000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021911s000_TOC.cfm 2/19/2009
AP011/14/2008N21876000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021911s000_SumR.pdf 2/19/2009
AP011/14/2008N23888000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088564.pdf 11/16/2009
AP010/16/2009SLR24129004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021911s004ltr.pdf 11/24/2009
AP011/8/2010SLR26916005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021911s005lbl.pdf 11/8/2010
AP011/8/2010SLR26923005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021911s005ltr.pdf 11/10/2010
AP03/3/2011SLR28129007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf 3/7/2011
AP03/3/2011SLR28184007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201367s000,021911s007ltr.pdf 3/8/2011
AP06/10/2011SLR29027008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021911s008,201367s001ltr.pdf 6/3/2011
AP06/6/2013SCM       
AP02/12/2015SLR41853012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s012,201367Orig1s003ltr.pdf 2/17/2015
AP02/12/2015SLR41988012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s012lbl.pdf 3/3/2015
AP06/25/2015SLR43119013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s013,201367Orig1s005ltr.pdf 6/26/2015
AP06/25/2015SLR43184013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.pdf 7/1/2015
AP06/17/2016SCM       
AP08/22/2016SCM       




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