Meclofenamate Sodium

ANDA 71469, held by Ani Pharms. Meclofenamate Sodium.

As of Nov 15, 2026, ANDA 71469 (Meclofenamate Sodium), held by Ani Pharms, was first approved by FDA on Apr 15, 1987, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 15, 1987
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Apr 15, 1987	Original application	Approved	None posted

Products

2 strengths and forms


Meclofenamate SodiumEQ 100MG BASE · capsule;oral	Meclofenamate Sodium	Discontinued
Meclofenamate SodiumEQ 50MG BASE · capsule;oral	Meclofenamate Sodium	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 24Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 23Labeling · Standard review	Approved	None posted
Apr 25, 2001	Supplement 21Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 19Manufacturing	Approved	None posted
Apr 29, 1996	Supplement 17Manufacturing	Approved	None posted
Oct 21, 1994	Supplement 18Labeling	Approved	None posted
Feb 12, 1993	Supplement 16Labeling	Approved	None posted
Jun 25, 1992	Supplement 15Manufacturing	Approved	None posted
Aug 7, 1991	Supplement 13Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 14Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 12Manufacturing	Approved	None posted
Apr 17, 1989	Supplement 11Labeling	Approved	None posted
Feb 14, 1989	Supplement 10Labeling	Approved	None posted
Aug 29, 1988	Supplement 9Labeling	Approved	None posted
Jul 12, 1988	Supplement 8Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 7Manufacturing	Approved	None posted
Jul 12, 1988	Supplement 6Manufacturing	Approved	None posted
Nov 6, 1987	Supplement 2Manufacturing	Approved	None posted
Nov 6, 1987	Supplement 1Manufacturing	Approved	None posted
Apr 15, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71469
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