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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 215548

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NDA 215548 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 215548

Tradename:	FENOPROFEN CALCIUM
Applicant:	Misemer
Ingredient:	fenoprofen calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 215548

Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	May 16, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 300MG BASE
Approval Date:	May 16, 2023	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 400MG BASE
Approval Date:	May 16, 2023	TE:		RLD:	No

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