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FDA Drug Application 020690 by EISAI INC

Application Number020690
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/25/1996N       
AP08/13/1998SCS       
AP08/13/1998SCE       
AP08/18/1998SLR       
AP010/16/1998SCM       
AP011/4/1998SCM       
AP02/28/2000SLR       
AP02/10/1999SCP       
AP08/18/1999SCM       
AP05/5/2004SLR8547011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20690slr011ltr.pdf 5/7/2004
AP05/5/2004SLR27871011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020690_s011_aricept.pdf 2/15/2011
AP02/28/2000SLR       
AP03/28/2000SCM       
AP09/21/2000SCP       
AP06/20/2001SLR       
AP010/3/2001SCS       
AP01/7/2002SCM       
AP01/7/2002SCM       
AP010/13/2006SE115116026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020690s026,021720s003LTR.pdf 10/18/2006
AP010/13/2006SE115131026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020690s026,021720s003lbl.pdf 10/18/2006
AP04/4/2013SLR35663031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021720Orig1s007,020690Orig1s031ltr.pdf 4/9/2013
AP012/2/2010SLR27100033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022568s004,020690s033,021720s006ltr.pdf 11/30/2010
AP012/2/2010SLR27118033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022568s004,020690s033,021720s006lbl.pdf 12/1/2010
AP03/1/2012SLR32011035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022568s005,020690s035,021720s008ltr_corrected.pdf 3/5/2012
AP03/1/2012SLR32073035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf 3/9/2012
AP09/4/2012SLR33649036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020690Orig1s036,021720Orig1s009,022568Orig1s006ltr.pdf 9/6/2012
AP09/4/2012SLR33842036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s036,021720s009,022568s006lbl.pdf 9/26/2012
AP09/6/2013SLR36996037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020690s037,021720s010,022568s007lbl.pdf 9/9/2013
AP09/6/2013SLR37034037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020690Orig1s037,021720Origs010,022568Orig1s007ltr.pdf 9/10/2013
AP07/20/2015SLR43435039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022568Orig1s008,021720Orig1s012,020690Orig1s039ltr.pdf 7/22/2015
AP07/20/2015SLR43450039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020690s039,021720s012,022568s008lbl.pdf 7/22/2015
AP08/17/2016SCM       




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