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FDA Drug Application 021720 by EISAI INC

Application Number021720
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
AP010/18/2004N10441000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21720ltr.pdf 10/22/2004
AP010/18/2004N10451000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21720lbl.pdf 10/22/2004
AP010/18/2004N14259000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021720_s000_AriceptTOC.cfm 6/8/2006
AP010/13/2006SE115117003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020690s026,021720s003LTR.pdf 10/18/2006
AP010/13/2006SE115132003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020690s026,021720s003lbl.pdf 10/18/2006
AP012/2/2010SLR27101006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s004,020690s033,021720s006ltr.pdf 11/30/2010
AP012/2/2010SLR27117006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,021720s006lbl.pdf 12/1/2010
AP04/4/2013SLR35662007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021720Orig1s007,020690Orig1s031ltr.pdf 4/9/2013
AP03/1/2012SLR32012008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022568s005,020690s035,021720s008ltr_corrected.pdf 3/5/2012
AP03/1/2012SLR32072008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf 3/9/2012
AP09/4/2012SLR33650009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020690Orig1s036,021720Orig1s009,022568Orig1s006ltr.pdf 9/6/2012
AP09/4/2012SLR33843009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf 9/26/2012
AP09/6/2013SLR36995010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020690s037,021720s010,022568s007lbl.pdf 9/9/2013
AP09/6/2013SLR37035010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020690Orig1s037,021720Origs010,022568Orig1s007ltr.pdf 9/10/2013
AP07/20/2015SLR43434012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022568Orig1s008,021720Orig1s012,020690Orig1s039ltr.pdf 7/22/2015
AP07/20/2015SLR43449012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020690s039,021720s012,022568s008lbl.pdf 7/22/2015




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