Viewing data from:

PONSTEL

NDA

MEFENAMIC ACID | N015034 | AVION PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Different Drugs to Control Post Root Canal Treatment Pain NCT02417337	Phase 2	Completed	University of Khartoum	185	2012-08 → 2015-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain7 active DMFs5 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

YUNG ZIP CHEMICAL IND CO LTDMEFENAMIC ACID

DMF 56771984

WANBURY LTDMEFENAMIC ACID USP

DMF 164912003

CHENG FONG CHEMICAL CO LTDMEFENAMIC ACID

DMF 189042005

TAI HENG INDUSTRY CO LTDMEFENAMIC ACID USP

DMF 203742007

WISDOM PHARMACEUTICAL CO LTDMEFENAMIC ACID

DMF 265892013

SOLARA ACTIVE PHARMA SCIENCES LTDMEFENAMIC ACID USP ( PRODUCT CODE : 05P)

DMF 296742015

NIRA LIFE SCIENCES PVT LTDMEFENAMIC ACID BP

DMF 364152021

YAMAMOTO CHEMICAL INDUSTRIES CO LTDInactiveMEFENAMIC ACID

DMF 63281986

WYCKOFF CHEMICAL CO INCInactiveMEFENAMIC ACID

DMF 79281989

QUIMICA SINTETICA SAInactiveMEFENAMIC ACID

DMF 91851991

TONIRA PHARMA LTDInactiveMEFENAMIC ACID

DMF 207782007

SOUVIN PHARMACEUTICAL I PVT LTDInactiveMEFENAMIC ACID BP

DMF 267712012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 27, 2026	SUPPL -47	View Letter (PDF)
Nov 25, 2024	SUPPL -46	View Letter (PDF)
Apr 29, 2021	SUPPL -45	View Letter (PDF)
May 11, 2016	SUPPL -44	View Letter (PDF)
Mar 17, 2008	SUPPL -40	View Letter (PDF)
Jan 20, 2006	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#003 — 250MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.