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FDA Drug Application 202834 by EISAI INC

Application Number202834
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
AP010/22/2012N34174000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202834lbl.pdf 10/26/2012
AP010/22/2012N34177000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202834Orig1s000ltr.pdf 10/26/2012
AP010/22/2012N34200000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM326088.pdf 10/29/2012
AP010/22/2012N34493000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202834Orig1s000TOC.cfm 11/28/2012
AP06/30/2013SLR36434001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202834Orig1s001ltr.pdf 7/3/2013
AP06/30/2013SLR36531001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202834s001lbl.pdf 7/11/2013
AP09/2/2013SCM       
AP02/24/2014SLR38597003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s003ltr.pdf 2/26/2014
AP02/14/2014SLR38533004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s004ltr.pdf 2/19/2014
AP02/14/2014SLR38540004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf 2/19/2014
AP06/19/2015SE843105005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202834s005lbl.pdf 6/23/2015
AP06/19/2015SE843111005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202834Orig1s005ltr.pdf 6/24/2015
AP011/14/2014SLR41004006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s006ltr.pdf 11/17/2014
AP011/14/2014SLR41047006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s006lbl.pdf 11/20/2014
AP012/14/2015SCM       
AP09/3/2015SCM       
AP012/23/2015SCM       




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