NDA 022568

EISAI INC

FDA Drug Application

Application #022568

Documents

• Letter: 2010-07-28
• Letter: 2012-03-05
• Letter: 2013-09-10
• Letter: 2015-07-22
• Label: 2012-09-26
• Summary Review: 2011-02-17
• Letter: 2010-11-30
• Letter: 2012-09-06
• Label: 2010-07-30
• Label: 2010-12-01
• Label: 2012-03-09
• Label: 2013-09-09
• Label: 2015-07-22
• Review: 2010-12-01
• Label: 2018-12-19

Application Sponsors

NDA 022568

EISAI INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

23MG

1

ARICEPT

DONEPEZIL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2010-07-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2010-12-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2012-03-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	2012-09-04	STANDARD
LABELING; Labeling	SUPPL	7	AP	2013-09-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-07-20	STANDARD
LABELING; Labeling	SUPPL	11	AP	2018-12-18	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	6
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	6
SUPPL	11	Null	7

TE Codes

001

Prescription

AB

CDER Filings

EISAI INC

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(
    [0] => Array
        (
            [ApplNo] => 22568
            [companyName] => EISAI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARICEPT","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"23MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/18\/2018","submission":"SUPPL-11","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-8","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-7","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-6","supplementCategories":"Labeling-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-5","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-5","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-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022568s004,020690s033,021720s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022568s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ARICEPT","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"23MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-18
        )

)