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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074431

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NDA 074431 describes FLURBIPROFEN, which is a drug marketed by Ivax Sub Teva Pharms, Natco Pharma, New Heightsrx, Pliva, Rising, Sun Pharm Inds Inc, Teva, Theragen, and Bausch And Lomb, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the FLURBIPROFEN profile page.

The generic ingredient in FLURBIPROFEN is flurbiprofen sodium. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.

Summary for 074431

Tradename:	FLURBIPROFEN
Applicant:	New Heightsrx
Ingredient:	flurbiprofen
Patents:	0

Pharmacology for NDA: 074431

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 074431

Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 074431

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074431	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0711	0093-0711-01	100 TABLET, FILM COATED in 1 BOTTLE (0093-0711-01)
FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074431	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0711	0093-0711-05	500 TABLET, FILM COATED in 1 BOTTLE (0093-0711-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	May 31, 1995	TE:		RLD:	No

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