Orange Book product · Brand (NDA)

KEPPRA XR

LEVETIRACETAM

Brand (NDA)NDA 022285TE ABRX UCB INC

Sep 12, 2008

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 12, 2008
18 yr ago
Today
Patent 7858122 expires
Listed drug product patent expiration.
Sep 17, 2028
in 2 yr 3 mo

Active ingredient

LEVETIRACETAM

Strength

500MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 022285

Product number

001

Marketing status

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
7858122	Sep 17, 2028	in 2 yr 3 mo	Product