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FDA Drug Application 022244 by EISAI INC

Application Number022244
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
AP012/12/2008N21381000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022244s000ltr.pdf 12/19/2008
AP012/12/2008N21478000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022244lbl.pdf 1/2/2009
AP012/12/2008N21841000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022244s000TOC.cfm 2/13/2009
AP012/12/2008N21842000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022244s000_SumR.pdf 2/13/2009
AP01/21/2010SLR24596006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022244s006lbl.pdf 1/24/2010
AP01/21/2010SLR24682006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022244s006ltr.pdf 1/29/2010
AP01/21/2010SLR31995006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022244Orig1s006.pdf 3/2/2012




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