Last Updated: May 10, 2026

Details for New Drug Application (NDA): 072981

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NDA 072981 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, Pharmaco, 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 072981

Tradename:	FENOPROFEN CALCIUM
Applicant:	Watson Labs
Ingredient:	fenoprofen calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 072981

Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Aug 19, 1991	TE:		RLD:	No

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