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Orange Book product · Generic (ANDA)

DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE

Generic (ANDA)ANDA 077975DISCN SUN PHARM INDUSTRIES

At a glance

Dec 11, 2009

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 11, 2009

    16 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DONEPEZIL HYDROCHLORIDE

Strength

5MG

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

Not listed

Application

ANDA 077975

Product number

002

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.