Orange Book product · Brand (NDA)

NAMENDA XR

MEMANTINE HYDROCHLORIDE

Brand (NDA)NDA 022525DISCN ABBVIE

Jun 21, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 21, 2010
16 yr 3 mo ago
Today
Patent 8039009 expires
Listed method-of-use patent (U-539) expiration.
Mar 24, 2029
in 2 yr 10 mo
Patent 8039009*PED expires
Listed listed patent expiration.
Sep 24, 2029
in 3 yr 4 mo

Active ingredient

MEMANTINE HYDROCHLORIDE

Strength

7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 022525

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8039009	Mar 24, 2029	in 2 yr 10 mo	U-539
8039009*PED	Sep 24, 2029	in 3 yr 4 mo