Orange Book product · Brand (NDA)

OZOBAX

BACLOFEN

Brand (NDA)NDA 208193DISCN METACEL PHARMS LLC

Sep 18, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 18, 2019
6 yr 10 mo ago
Today
Patent 10610502 expires
Listed method-of-use patent (U-2779) expiration.
Aug 30, 2039
in 13 yr 5 mo

Active ingredient

BACLOFEN

Strength

5MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 208193

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
10610502	Aug 30, 2039	in 13 yr 5 mo	U-2779