← FDA DRUG APPROVALS

FDA NDA · NDA022568

ARICEPT

donepezil hydrochloride

Sponsor: EISAI INC

APPLICATION
NDA022568
TYPE
NDA
ORIGINAL APPROVAL
2010-07-23
LATEST ACTION
2018-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ARICEPT · ReferencePrescription
DONEPEZIL HYDROCHLORIDE 23MG · TABLET · ORAL

Approval history

2018-12-18Labeling · Supplement 11 · standard — Label ↗AP
2015-07-20Labeling · Supplement 8 · standard — Label ↗AP
2013-09-06Labeling · Supplement 7 · standard — Label ↗AP
2012-09-04Labeling · Supplement 6 · standard — Label ↗AP
2012-03-07Labeling · Supplement 5 · standard — Label ↗AP
2010-12-02Labeling · Supplement 4 · standard — Label ↗AP
2010-07-23Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →