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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 072267

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NDA 072267 describes FENOPROFEN CALCIUM, which is a drug marketed by Am Therap, Halsey, Misemer, Par Pharm, Quantum Pharmics, Rising, Warner Chilcott, Watson Labs, Ani Pharms, Dava Pharms Inc, Ivax Sub Teva Pharms, Key Therap, Strides Pharma Intl, Sun Pharm Industries, Usl Pharma, and Watson Labs Teva, and is included in thirty-two NDAs. It is available from four suppliers. Additional details are available on the FENOPROFEN CALCIUM profile page.

The generic ingredient in FENOPROFEN CALCIUM is fenoprofen calcium. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fenoprofen calcium profile page.

Summary for 072267

Tradename:	FENOPROFEN CALCIUM
Applicant:	Key Therap
Ingredient:	fenoprofen calcium
Patents:	0

Pharmacology for NDA: 072267

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 072267

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 072267

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOPROFEN CALCIUM	fenoprofen calcium	TABLET;ORAL	072267	ANDA	Proficient Rx LP	82804-129	82804-129-90	90 TABLET, FILM COATED in 1 BOTTLE (82804-129-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 600MG BASE
Approval Date:	Aug 17, 1988	TE:		RLD:	No

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