Tolmetin Sodium

ANDA 73311, held by Sun Pharm Industries. Tolmetin Sodium.

As of Nov 15, 2026, ANDA 73311 (Tolmetin Sodium), held by Sun Pharm Industries, was first approved by FDA on Nov 27, 1991, with 10 approved supplements and 0 published complete response letters.

First approved: Nov 27, 1991
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 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 11 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Apr 30, 2021	Supplement 18Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 17Labeling · Standard review	Approved	None posted
Apr 3, 2008	Supplement 16Labeling	Approved	None posted
May 16, 2006	Supplement 15Labeling	Approved	None posted
May 16, 2000	Supplement 5Manufacturing	Approved	None posted
May 16, 2000	Supplement 4Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 3Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 2Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 1Manufacturing	Approved	None posted
Nov 27, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 73311
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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