Orange Book product · Brand (NDA)

COLAZAL

BALSALAZIDE DISODIUM

Brand (NDA)NDA 020610TE ABRX VALEANT PHARMS INTL

Jul 18, 2000

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 18, 2000
26 yr 4 mo ago
Today
Patent 7452872 expires
Listed method-of-use patent (U-141) expiration.
Aug 24, 2026
in 2 mo
Patent 7625884 expires
Listed method-of-use patent (U-141) expiration.
Aug 24, 2026
in 2 mo
Patent 7452872*PED expires
Listed listed patent expiration.
Feb 24, 2027
in 8 mo
Patent 7625884*PED expires
Listed listed patent expiration.
Feb 24, 2027
in 8 mo

Active ingredient

BALSALAZIDE DISODIUM

Strength

750MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 020610

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
7452872	Aug 24, 2026	in 2 mo	U-141
7625884	Aug 24, 2026	in 2 mo	U-141
7452872*PED	Feb 24, 2027	in 8 mo
7625884*PED	Feb 24, 2027	in 8 mo