Tolmetin Sodium

ANDA 73290, held by Pharmazone. Tolmetin Sodium.

As of Nov 15, 2026, ANDA 73290 (Tolmetin Sodium), held by Pharmazone, was first approved by FDA on Nov 27, 1991, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 27, 1991
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Nov 27, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tolmetin SodiumEQ 400MG BASE · capsule;oral	Tolmetin Sodium	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 18Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Jan 11, 2007	Supplement 13Labeling	Approved	None posted
Mar 8, 2006	Supplement 12Labeling	Approved	None posted
Mar 17, 1998	Supplement 4Manufacturing	Approved	None posted
Jul 22, 1994	Supplement 2Manufacturing	Approved	None posted
Jul 18, 1994	Supplement 3Manufacturing	Approved	None posted
Mar 31, 1994	Supplement 1Manufacturing	Approved	None posted
Nov 27, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 73290
Drugs@FDA: Overview at FDA
Company: Pharmazone

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