Orange Book product · Brand (NDA)

FLEQSUVY

BACLOFEN

Brand (NDA)NDA 215602TE ABRX AZURITY

Feb 04, 2022

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 04, 2022
4 yr 5 mo ago
Today
Patent 11446246 expires
Listed method-of-use patent (U-3433) expiration.
Sep 08, 2037
in 11 yr 5 mo
Patent 11324696 expires
Listed drug product patent expiration.
Sep 29, 2037
in 11 yr 5 mo

Active ingredient

BACLOFEN

Strength

25MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Application

NDA 215602

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
11446246	Sep 08, 2037	in 11 yr 5 mo	U-3433
11324696	Sep 29, 2037	in 11 yr 5 mo	Product