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Orange Book product · Generic (ANDA)

DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE

Generic (ANDA)ANDA 203419DISCN CHARTWELL RX

At a glance

Apr 12, 2016

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 12, 2016

    10 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DONEPEZIL HYDROCHLORIDE

Strength

23MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 203419

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DONEPEZIL HYDROCHLORIDE

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.