Tolmetin Sodium

Relieves rheumatoid arthritis and osteoarthritis. ANDA 74473, held by Rising. Tolmetin Sodium.

As of Nov 15, 2026, ANDA 74473 (Tolmetin Sodium), held by Rising, was first approved by FDA on Aug 30, 1994, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 30, 1994
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Carefully consider the potential benefits and risks of TOLECTIN tablets, USP and other treatment options before deciding to use TOLECTIN tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). TOLECTIN tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. TOLECTIN tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. TOLECTIN tablets are also indicated for treatment of juvenile rheumatoid arthritis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 30, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tolmetin SodiumEQ 600MG BASE · tablet;oral	Tolmetin Sodium	Rx

All 11 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Aug 31, 2023	Supplement 17Manufacturing	Approved	None posted
Apr 28, 2021	Supplement 15Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Jul 25, 2008	Supplement 9Labeling	Approved	None posted
Sep 22, 2006	Supplement 6Labeling	Approved	None posted
Aug 2, 2000	Supplement 4Manufacturing	Approved	None posted
Apr 30, 1999	Supplement 2Manufacturing	Approved	None posted
Apr 30, 1999	Supplement 3Manufacturing	Approved	None posted
Feb 1, 1995	Supplement 1Manufacturing	Approved	None posted
Aug 30, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74473
Drugs@FDA: Overview at FDA
Company: Rising 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