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FDA Drug Application 022568 by EISAI INC

Application Number022568
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
AP07/23/2010N26032000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s000ltr.pdf 7/28/2010
AP07/23/2010N26052000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s000lbl.pdf 7/30/2010
AP07/23/2010N27112000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022568_aricept_toc.cfm 12/1/2010
AP07/23/2010N27908000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022568Orig1s000SumR.pdf 2/17/2011
AP012/2/2010SLR27099004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s004,020690s033,021720s006ltr.pdf 11/30/2010
AP012/2/2010SLR27119004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,021720s006lbl.pdf 12/1/2010
AP03/1/2012SLR32010005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022568s005,020690s035,021720s008ltr_corrected.pd 3/5/2012
AP03/1/2012SLR32071005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf 3/9/2012
AP09/4/2012SLR33651006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020690Orig1s036,021720Orig1s009,022568Orig1s006ltr.pdf 9/6/2012
AP09/4/2012SLR33844006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf 9/26/2012
AP09/6/2013SLR36994007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020690s037,021720s010,022568s007lbl.pdf 9/9/2013
AP09/6/2013SLR37036007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020690Orig1s037,021720Origs010,022568Orig1s007ltr.pdf 9/10/2013
AP07/20/2015SLR43433008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022568Orig1s008,021720Orig1s012,020690Orig1s039ltr.pdf 7/22/2015
AP07/20/2015SLR43448008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020690s039,021720s012,022568s008lbl.pdf 7/22/2015




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