Last Updated: November 13, 2026

Details for New Drug Application (NDA): 074358

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NDA 074358 describes FLURBIPROFEN, which is a drug marketed by Genus, Ivax Sub Teva Pharms, Natco Pharma, Pliva, Rising, Sun Pharm Inds Inc, Teva, Theragen, and Bausch And Lomb, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the FLURBIPROFEN profile page.

The generic ingredient in FLURBIPROFEN is flurbiprofen sodium. There are two 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 074358

Tradename:	FLURBIPROFEN
Applicant:	Natco Pharma
Ingredient:	flurbiprofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 074358

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:	Jun 20, 1994	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jun 20, 1994	TE:		RLD:	No

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