Treats mild to moderate ulcerative colitis. ANDA 75339, held by Nuvo Pharms Inc. Sulfasalazine.
As of Nov 15, 2026, ANDA 75339 (Sulfasalazine), held by Nuvo Pharms Inc, was first approved by FDA on Jan 11, 2002, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE SULFASALAZINE DELAYED RELEASE Tablets, USP are indicated: a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;b)for the prolongation of the remission period between acute attacks of ulcerative colitis;c)in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sulfasalazine500MG · tablet, delayed release;oral | Sulfasalazine | Rx |
| Feb 23, 2016 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 18, 2015 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 18, 2015 | Supplement 14Labeling · Standard review | Approved | None posted |
| Mar 22, 2013 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 3, 2012 | Supplement 7Labeling | Approved | None posted |
| May 13, 2004 | Supplement 2Labeling | Approved | None posted |
| Jan 11, 2002 | Original application | Approved |
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
