Meclofenamate Sodium

Reduces fever. ANDA 71081, held by Mylan. Meclofenamate Sodium.

As of Nov 15, 2026, ANDA 71081 (Meclofenamate Sodium), held by Mylan, was first approved by FDA on Sep 3, 1986, with 15 approved supplements and 0 published complete response letters.

First approved: Sep 3, 1986
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Meclofenamate sodium capsules are indicated:

For reduction of fever in adults
For relief of mild to moderate pain in adults
For relief of signs and symptoms of juvenile arthritis.
For relief of the signs and symptoms of rheumatoid arthritis
For relief of the signs and symptoms of osteoarthritis.
For treatment of primary dysmenorrhea.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Sep 3, 1986	Original application	Approved	None posted

Products

2 strengths and forms


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

All 16 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 26Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 21Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 19Labeling · Standard review	Approved	None posted
Sep 4, 2015	Supplement 18Labeling · Standard review	Approved	None posted
Oct 9, 2002	Supplement 13Manufacturing	Approved	None posted
Oct 9, 2002	Supplement 12Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 11Manufacturing	Approved	None posted
May 5, 1994	Supplement 10Labeling	Approved	None posted
Jan 28, 1994	Supplement 9Manufacturing	Approved	None posted
Aug 5, 1992	Supplement 7Labeling	Approved	None posted
Jan 31, 1990	Supplement 6Manufacturing	Approved	None posted
Aug 4, 1989	Supplement 5Labeling	Approved	None posted
Feb 8, 1989	Supplement 4Labeling	Approved	None posted
Apr 9, 1987	Supplement 3Manufacturing	Approved	None posted
Nov 5, 1986	Supplement 2Manufacturing	Approved	None posted
Sep 3, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 71081
Drugs@FDA: Overview at FDA
Company: Mylan

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