Meclofenamate Sodium

Sold as Meclomen. Every FDA application for this active ingredient: 1 branded and 20 generic.

As of Nov 15, 2026, FDA lists 21 applications for Meclofenamate Sodium (sold as Meclomen), first approved Jun 25, 1980, with 3 new uses approved and 0 published complete response letters.

First approved: Jun 25, 1980
Applications: 21
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $189K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Meclofenamate Sodium	Part D	$189K	-27%	102

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Implantable Microdevice In Primary Brain TumorsGrade II Glioma, Grade III Glioma · Oliver Jonas	Early phase 1	Recruiting	Oct 23, 2019
Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor PrimaryRecurrent Brain Metastases, Progressive Brain Metastases · Memorial Sloan Kettering Cancer Center	Not applicable	Active, not recruiting	Apr 29, 2015

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 25, 1980	MeclomenNDA 18006 · New molecular entity	Parke Davis	15	Discontinued
Sep 3, 1986	Meclofenamate SodiumANDA 71081	Mylan	15	Marketed
Apr 15, 1987	Meclofenamate SodiumANDA 71469	Ani Pharms	20	Discontinued
Nov 29, 1988	Meclofenamate SodiumANDA 72262	Chartwell Rx	7	Discontinued
Nov 29, 1988	Meclofenamate SodiumANDA 72263	Chartwell Rx	8	Discontinued
Mar 20, 1989	Meclofenamate SodiumANDA 72809	Barr	3	Discontinued
Mar 20, 1989	Meclofenamate SodiumANDA 72848	Barr	3	Discontinued
—	Meclofenamate SodiumANDA 70400	Watson Labs	0	Discontinued
—	Meclofenamate SodiumANDA 70401	Watson Labs	0	Discontinued
—	Meclofenamate SodiumANDA 71007	Usl Pharma	0	Discontinued
—	Meclofenamate SodiumANDA 71008	Usl Pharma	0	Discontinued
—	Meclofenamate SodiumANDA 71362	Am Therap	0	Discontinued
—	Meclofenamate SodiumANDA 71363	Am Therap	0	Discontinued
—	MeclodiumANDA 71380	Quantum Pharmics	0	Discontinued
—	MeclodiumANDA 71381	Quantum Pharmics	0	Discontinued
—	Meclofenamate SodiumANDA 71640	Watson Labs	0	Discontinued
—	Meclofenamate SodiumANDA 71641	Watson Labs	0	Discontinued
—	Meclofenamate SodiumANDA 71684	Vitarine	0	Discontinued
—	Meclofenamate SodiumANDA 71710	Vitarine	0	Discontinued
—	Meclofenamate SodiumANDA 72077	Par Pharm	0	Discontinued
—	Meclofenamate SodiumANDA 72078	Par Pharm	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA