Orange Book product · Brand (NDA)

LAMICTAL XR

LAMOTRIGINE

Brand (NDA)NDA 022115TE ABRX GLAXOSMITHKLINE LLC

May 29, 2009

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 29, 2009
17 yr 4 mo ago
Today
Patent 8637512 expires
Listed drug product patent expiration.
Jan 07, 2029
in 2 yr 7 mo

Active ingredient

LAMOTRIGINE

Strength

25MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 022115

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
8637512	Jan 07, 2029	in 2 yr 7 mo	Product