Colazal

NDA 20610, held by Valeant Pharms Intl. Balsalazide Disodium.

As of Nov 14, 2026, NDA 20610 (Colazal), held by Valeant Pharms Intl, was first approved by FDA on Jul 18, 2000, with 15 approved supplements and 0 published complete response letters.

First approved: Jul 18, 2000
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Dec 20, 2006	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Clinical Pharmacology Review Pediatric Medical Review
Jul 18, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Written Request

Products

1 strengths and forms

Product	Active ingredient	Marketing
Colazal750MG · capsule;oral	Balsalazide Disodium	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 27Labeling · Standard review	Approved	Label Letter
Oct 24, 2023	Supplement 26Labeling · Standard review	Approved	Label Letter
Nov 16, 2022	Supplement 25Labeling · Standard review	Approved	Letter Label
Nov 1, 2021	Supplement 24Labeling · Standard review	Approved	Letter Label
Oct 1, 2020	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 21, 2019	Supplement 21Labeling · Standard review	Approved	Letter Label
Jan 5, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 5, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 9, 2008	Supplement 18Labeling · Standard review	Approved	Letter
Nov 2, 2007	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 20, 2006	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Clinical Pharmacology Review Pediatric Medical Review
Sep 21, 2006	Supplement 14Labeling · Standard review	Approved	Label Letter
Mar 10, 2006	Supplement 13Manufacturing · Standard review	Approved	Letter
Jun 18, 2002	Supplement 1Labeling · Standard review	Approved	Letter
Feb 7, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 18, 2000	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Written Request

Identifiers

Application: NDA 20610
Drugs@FDA: Overview at FDA
Company: Valeant Pharmaceuticals International

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters