Orange Book product · Brand (NDA)

GIAZO

BALSALAZIDE DISODIUM

Brand (NDA)NDA 022205DISCN VALEANT PHARMS INTL

Feb 03, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 03, 2012
14 yr 7 mo ago
Today
Patent 9192616 expires
Listed method-of-use patent (U-1229) expiration.
Aug 02, 2026
in 1 mo
Patent 7452872 expires
Listed method-of-use patent (U-1229) expiration.
Aug 24, 2026
in 2 mo
Patent 7625884 expires
Listed method-of-use patent (U-1229) expiration.
Aug 24, 2026
in 2 mo
Patent 8497256 expires
Listed method-of-use patent (U-1229) expiration.
Jun 23, 2031
in 5 yr 1 mo

Active ingredient

BALSALAZIDE DISODIUM

Strength

1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022205

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
9192616	Aug 02, 2026	in 1 mo	U-1229
7452872	Aug 24, 2026	in 2 mo	U-1229
7625884	Aug 24, 2026	in 2 mo	U-1229
8497256	Jun 23, 2031	in 5 yr 1 mo	U-1229