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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 019583

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NDA 019583 describes RELAFEN, which is a drug marketed by Smithkline Beecham and is included in one NDA. Additional details are available on the RELAFEN profile page.

The generic ingredient in RELAFEN is nabumetone. There are twenty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nabumetone profile page.

Summary for 019583

Tradename:	RELAFEN
Applicant:	Smithkline Beecham
Ingredient:	nabumetone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 24, 1991	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 24, 1991	TE:		RLD:	Yes

Expired US Patents for NDA 019583

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-001	Dec 24, 1991	⤷ Get Started Free	⤷ Get Started Free
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991	⤷ Get Started Free	⤷ Get Started Free
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-002	Dec 24, 1991	⤷ Get Started Free	⤷ Get Started Free
Smithkline Beecham	RELAFEN	nabumetone	TABLET;ORAL	019583-001	Dec 24, 1991	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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