Meclofenamate Sodium

ANDA 72262, held by Chartwell Rx. Meclofenamate Sodium.

As of Nov 15, 2026, ANDA 72262 (Meclofenamate Sodium), held by Chartwell Rx, was first approved by FDA on Nov 29, 1988, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 29, 1988
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 29, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meclofenamate SodiumEQ 50MG BASE · capsule;oral	Meclofenamate Sodium	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Apr 26, 2021	Supplement 6Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Jul 31, 1996	Supplement 3Labeling	Approved	None posted
Feb 10, 1995	Supplement 2Manufacturing	Approved	None posted
Dec 21, 1992	Supplement 1Labeling	Approved	None posted
Nov 29, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72262
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