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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074411

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NDA 074411 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 074411

Tradename:	FLURBIPROFEN
Applicant:	Ivax Sub Teva Pharms
Ingredient:	flurbiprofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 074411

Analgesics
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 31, 1995	TE:		RLD:	No

Profile for product number 002

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

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