Back to FDA Applications sponsored by EISAI INC

FDA Drug Application 022529 by EISAI INC

Application Number022529
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
AP06/27/2012N33032000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022529lbl.pdf 6/27/2012
AP06/27/2012N33040000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022529Orig1s000ltr.pdf 6/27/2012
AP06/27/2012N33405000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022529Orig1s000TOC.cfm 8/7/2012
AP01/4/2013SCM       
AP011/1/2013SCM       
AP012/9/2014SLR41210003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022529Orig1s003ltr.pdf 12/11/2014
AP012/9/2014SLR45577003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022529s003lbl.pdf 4/4/2016
AP07/30/2014SCM       
AP04/6/2016SCM       




Back to FDA Applications sponsored by EISAI INC