Meclofenamate Sodium

ANDA 72848, held by Barr. Meclofenamate Sodium.

As of Nov 15, 2026, ANDA 72848 (Meclofenamate Sodium), held by Barr, was first approved by FDA on Mar 20, 1989, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 20, 1989
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 20, 1989	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


May 10, 1994	Supplement 6Labeling	Approved	None posted
May 27, 1993	Supplement 5Labeling	Approved	None posted
Apr 3, 1989	Supplement 1Labeling	Approved	None posted
Mar 20, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 72848
Drugs@FDA: Overview at FDA
Company: Barr Laboratories

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