Relieves rheumatoid arthritis and osteoarthritis. ANDA 73588, held by Chartwell Rx. Tolmetin Sodium.
As of Nov 15, 2026, ANDA 73588 (Tolmetin Sodium), held by Chartwell Rx, was first approved by FDA on Jul 31, 1992, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of tolmetin sodium tablets and other treatment options before deciding to use tolmetin sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Tolmetin sodium tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium tablets are also indicated for treatment of juvenile rheumatoid arthritis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 1992 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tolmetin SodiumEQ 200MG BASE · tablet;oral | Tolmetin Sodium | Discontinued |
| Nov 21, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 5, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 24, 1994 | Supplement 1Manufacturing | Approved | None posted |
| Jul 31, 1992 | Original application | Approved | None posted |
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
