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Orange Book product · Generic (ANDA)

MEMANTINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE

Generic (ANDA)ANDA 205825TE ABRX AMNEAL PHARMS

At a glance

Oct 12, 2016

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 12, 2016

    9 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MEMANTINE HYDROCHLORIDE

Strength

7MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 205825

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of MEMANTINE 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.