Sulfasalazine

Treats mild to moderate ulcerative colitis. ANDA 80197, held by Chartwell. Sulfasalazine.

As of Nov 15, 2026, ANDA 80197 (Sulfasalazine), held by Chartwell, was first approved by FDA on Nov 12, 1973, with 14 approved supplements and 0 published complete response letters.

First approved: Nov 12, 1973
Supplements approved: 14
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 15 submissions below

Date	Submission	Status	Documents
Nov 12, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfasalazine500MG · tablet;oral	Sulfasalazine	Rx

All 15 submissions, including labeling and manufacturing supplements


Aug 24, 2023	Supplement 32Labeling · Standard review	Approved	None posted
Aug 24, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Aug 24, 2023	Supplement 28Labeling · Standard review	Approved	None posted
Nov 21, 1997	Supplement 26Manufacturing	Approved	None posted
Jun 10, 1994	Supplement 25Manufacturing	Approved	None posted
Apr 12, 1994	Supplement 24Labeling	Approved	None posted
May 28, 1993	Supplement 23Manufacturing	Approved	None posted
May 28, 1993	Supplement 22Labeling	Approved	None posted
Apr 26, 1991	Supplement 21Labeling	Approved	None posted
Feb 8, 1991	Supplement 20Labeling	Approved	None posted
Aug 1, 1989	Supplement 19Labeling	Approved	None posted
Jun 29, 1988	Supplement 16Manufacturing	Approved	None posted
Jun 29, 1988	Supplement 15Manufacturing	Approved	None posted
Apr 13, 1983	Supplement 11Manufacturing	Approved	None posted
Nov 12, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80197
Drugs@FDA: Overview at FDA
Company: Chartwell

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