Assyro AI

Orange Book product · Brand (NDA)

NAMENDA

MEMANTINE HYDROCHLORIDE

Brand (NDA)NDA 021487DISCN ABBVIE
View MEMANTINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Oct 16, 2003

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 16, 2003

    23 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

MEMANTINE HYDROCHLORIDE

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 021487

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.

Agent CTA Background

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

Book a Demo