Sulfasalazine

Treats mild to moderate ulcerative colitis. ANDA 85828, held by Watson Labs. Sulfasalazine.

As of Nov 15, 2026, ANDA 85828 (Sulfasalazine), held by Watson Labs, was first approved by FDA on Oct 21, 1977, with 28 approved supplements and 0 published complete response letters.

First approved: Oct 21, 1977
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Sulfasalazine tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Oct 21, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfasalazine500MG · tablet;oral	Sulfasalazine	Rx

All 29 submissions, including labeling and manufacturing supplements


Mar 4, 2025	Supplement 44Labeling · Standard review	Approved	None posted
Jul 26, 2022	Supplement 42Labeling · Standard review	Approved	None posted
Jul 26, 2022	Supplement 40Labeling · Standard review	Approved	None posted
Feb 25, 2015	Supplement 38Labeling · Standard review	Approved	None posted
Feb 25, 2015	Supplement 37Labeling · Standard review	Approved	None posted
Aug 21, 2013	Supplement 36Labeling · Standard review	Approved	None posted
Dec 31, 2010	Supplement 35Labeling	Approved	None posted
May 5, 2003	Supplement 34Labeling	Approved	None posted
Oct 27, 1998	Supplement 33Labeling	Approved	None posted
Apr 23, 1998	Supplement 32Labeling	Approved	None posted
Oct 8, 1997	Supplement 31Manufacturing	Approved	None posted
Oct 8, 1997	Supplement 30Manufacturing	Approved	None posted
May 27, 1997	Supplement 29Manufacturing	Approved	None posted
Mar 31, 1993	Supplement 28Labeling	Approved	None posted
Jul 22, 1991	Supplement 27Labeling	Approved	None posted
May 21, 1991	Supplement 26Labeling	Approved	None posted
Aug 15, 1988	Supplement 24Manufacturing	Approved	None posted
Aug 15, 1988	Supplement 23Manufacturing	Approved	None posted
Aug 15, 1988	Supplement 22Manufacturing	Approved	None posted
Aug 15, 1988	Supplement 21Manufacturing	Approved	None posted
Mar 4, 1988	Supplement 19Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 17Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 16Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 15Manufacturing	Approved	None posted
Apr 15, 1986	Supplement 14Manufacturing	Approved	None posted
Jul 22, 1983	Supplement 8Manufacturing	Approved	None posted
May 13, 1983	Supplement 7Manufacturing	Approved	None posted
May 13, 1983	Supplement 6Manufacturing	Approved	None posted
Oct 21, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85828
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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