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Orange Book product · Generic (ANDA)

DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE

Generic (ANDA)ANDA 201787TE ABRX MACLEODS PHARMS LTD

At a glance

Dec 14, 2012

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 14, 2012

    13 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DONEPEZIL HYDROCHLORIDE

Strength

5MG

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

AB

Application

ANDA 201787

Product number

001

Marketing status

RX

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.