NDA 020690

EISAI INC

FDA Drug Application

Application #020690

Documents

• Letter: 2010-11-30
• Letter: 2012-03-05
• Label: 2010-12-01
• Label: 2012-09-26
• Review: 2011-02-15
• Letter: 2004-05-07
• Letter: 2006-10-18
• Letter: 2013-04-09
• Letter: 2012-09-06
• Letter: 2013-09-10
• Letter: 2015-07-22
• Label: 2006-10-18
• Label: 2012-03-09
• Label: 2013-09-09
• Label: 2015-07-22
• Label: 2018-12-19
• Letter: 2018-12-21
• Review: 1997-04-11

Application Sponsors

NDA 020690

EISAI INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	10MG	1	ARICEPT	DONEPEZIL HYDROCHLORIDE
002	TABLET;ORAL	5MG	1	ARICEPT	DONEPEZIL HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-11-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-08-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-08-13	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1998-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-10-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-11-04	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2000-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-02-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-08-18	PRIORITY
LABELING; Labeling	SUPPL	11	AP	2004-05-04	STANDARD
LABELING; Labeling	SUPPL	12	AP	2000-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-03-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-09-21	PRIORITY
LABELING; Labeling	SUPPL	16	AP	2001-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-10-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-01-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-01-07	PRIORITY
EFFICACY; Efficacy	SUPPL	26	AP	2006-10-13	UNKNOWN
LABELING; Labeling	SUPPL	31	AP	2013-04-04	STANDARD
LABELING; Labeling	SUPPL	33	AP	2010-12-02	STANDARD
LABELING; Labeling	SUPPL	35	AP	2012-03-07	STANDARD
LABELING; Labeling	SUPPL	36	AP	2012-09-04	STANDARD
LABELING; Labeling	SUPPL	37	AP	2013-09-06	STANDARD
LABELING; Labeling	SUPPL	39	AP	2015-07-20	STANDARD
LABELING; Labeling	SUPPL	42	AP	2018-12-18	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	31	Null	7
SUPPL	33	Null	7
SUPPL	35	Null	7
SUPPL	36	Null	15
SUPPL	37	Null	15
SUPPL	39	Null	15
SUPPL	42	Null	33

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

EISAI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20690
            [companyName] => EISAI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARICEPT","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ARICEPT","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/18\/2018","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020690s042,021720s014,022568s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2015","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020690s039,021720s012,022568s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2013","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020690s037,021720s010,022568s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2012","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020690s036,021720s009,022568s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2012","submission":"SUPPL-36","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020690s036,021720s009,022568s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020690s035,021720s008,022568s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020690s035,021720s008,022568s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2010","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022568s004,020690s033,021720s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2006","submission":"SUPPL-26","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020690s026,021720s003lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ARICEPT","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ARICEPT","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-18
        )

)