Meclomen

NDA 18006, held by Parke Davis. Meclofenamate Sodium.

As of Nov 13, 2026, NDA 18006 (Meclomen), held by Parke Davis, was first approved by FDA on Jun 25, 1980, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 25, 1980
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

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


Jul 23, 1990	Supplement 11Efficacy (new indication or use)	Approved	None posted
Jul 23, 1990	Supplement 13Efficacy (new indication or use)	Approved	None posted
Aug 30, 1988	Supplement 9Efficacy (new indication or use)	Approved	None posted
Jun 25, 1980	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


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

All 16 submissions, including labeling and manufacturing supplements


Jul 23, 1990	Supplement 11Efficacy (new indication or use)	Approved	None posted
Jul 23, 1990	Supplement 13Efficacy (new indication or use)	Approved	None posted
May 14, 1990	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 9, 1989	Supplement 18Labeling	Approved	None posted
Aug 30, 1988	Supplement 9Efficacy (new indication or use)	Approved	None posted
Jun 7, 1988	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 10, 1987	Supplement 14Labeling	Approved	None posted
Nov 20, 1985	Supplement 12Labeling	Approved	None posted
May 15, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 9, 1983	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 13, 1983	Supplement 5Manufacturing · Standard review	Approved	None posted
May 10, 1982	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 22, 1981	Supplement 3Labeling	Approved	None posted
Apr 11, 1981	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 6, 1980	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 25, 1980	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18006
Drugs@FDA: Overview at FDA
Company: Parke-Davis

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