Sulfasalazine

Treats mild to moderate ulcerative colitis. ANDA 40349, held by Nuvo Pharms Inc. Sulfasalazine.

As of Nov 15, 2026, ANDA 40349 (Sulfasalazine), held by Nuvo Pharms Inc, was first approved by FDA on Jan 11, 2002, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 11, 2002
Supplements approved: 5
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 6 submissions below

Date	Submission	Status	Documents
Jan 11, 2002	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfasalazine500MG · tablet;oral	Sulfasalazine	Rx

All 6 submissions, including labeling and manufacturing supplements


Mar 25, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Mar 25, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Mar 22, 2013	Supplement 12Labeling · Standard review	Approved	None posted
Jan 20, 2011	Supplement 6Labeling	Approved	None posted
Mar 16, 2007	Supplement 4Labeling	Approved	None posted
Jan 11, 2002	Original application	Approved	Review

Identifiers

Application: ANDA 40349
Drugs@FDA: Overview at FDA
Company: Nuvo Pharmaceuticals

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