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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 075058

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NDA 075058 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 four 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 075058

Tradename:	FLURBIPROFEN
Applicant:	Sun Pharm Inds Inc
Ingredient:	flurbiprofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 075058

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:	Apr 27, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 27, 2001	TE:		RLD:	No

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