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FDA Drug Application 021719 by EISAI INC

Application Number021719
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/18/2004N10442000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21719ltr.pdf 10/22/2004
AP010/18/2004N10452000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21719lbl.pdf 10/22/2004
AP010/13/2006SE115130001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021719s001lbl.pdf 10/18/2006
AP010/13/2006SE115191001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021719s001ltr.pdf 10/23/2006




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