Orange Book product · Brand (NDA)

ARICEPT ODT

DONEPEZIL HYDROCHLORIDE

Brand (NDA)NDA 021720DISCN EISAI INC

View DONEPEZIL HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Oct 18, 2004

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Oct 18, 2004
22 yr ago
Today

Pharmaceutical detail

Active ingredient

DONEPEZIL HYDROCHLORIDE

Strength

5MG

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

Not listed

Application

NDA 021720

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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