← FDA DRUG APPROVALS

FDA NDA · NDA021720

ARICEPT ODT

Sponsor: EISAI INC

APPLICATION
NDA021720
TYPE
NDA
ORIGINAL APPROVAL
2004-10-18
LATEST ACTION
2018-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

ARICEPT ODT · ReferenceDiscontinued
DONEPEZIL HYDROCHLORIDE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
ARICEPT ODT · ReferenceDiscontinued
DONEPEZIL HYDROCHLORIDE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2018-12-18Labeling · Supplement 14 · standard — Label ↗AP
2015-07-20Labeling · Supplement 12 · standard — Label ↗AP
2013-09-06Labeling · Supplement 10 · standard — Label ↗AP
2013-04-04Labeling · Supplement 7 · standard — Letter ↗AP
2012-09-04Labeling · Supplement 9 · standard — Letter ↗AP
2012-03-07Labeling · Supplement 8 · standard — Label ↗AP
2010-12-02Labeling · Supplement 6 · standard — Label ↗AP
2006-10-13Efficacy · Supplement 3 · standard — Label ↗AP
2004-10-18Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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