Tolmetin Sodium

ANDA 74002, held by Chartwell Rx. Tolmetin Sodium.

As of Nov 15, 2026, ANDA 74002 (Tolmetin Sodium), held by Chartwell Rx, was first approved by FDA on Sep 27, 1993, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 27, 1993
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Sep 27, 1993	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Apr 5, 2021	Supplement 2Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Sep 27, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74002
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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