Tolmetin Sodium

ANDA 73527, held by Ani Pharms. Tolmetin Sodium.

As of Nov 15, 2026, ANDA 73527 (Tolmetin Sodium), held by Ani Pharms, was first approved by FDA on Jun 30, 1992, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1992
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
Jun 30, 1992	Original application	Approved	None posted

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 16Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 15Labeling · Standard review	Approved	None posted
Jan 27, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Jan 28, 2002	Supplement 5Manufacturing	Approved	None posted
Nov 2, 2001	Supplement 4Manufacturing	Approved	None posted
Jul 13, 2000	Supplement 3Manufacturing	Approved	None posted
Feb 3, 2000	Supplement 2Manufacturing	Approved	None posted
Jan 18, 1996	Supplement 1Manufacturing	Approved	None posted
Jun 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73527
Drugs@FDA: Overview at FDA
Company: ANI 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