Relafen

NDA 19583, held by Smithkline Beecham. Nabumetone.

As of Nov 13, 2026, NDA 19583 (Relafen), held by Smithkline Beecham, was first approved by FDA on Dec 24, 1991, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1991
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Dec 24, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Relafen500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nabumetone	DiscontinuedReference drug
Relafen750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Nabumetone	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 24, 2006	Supplement 25Labeling · Standard review	Approved	Letter Label
Aug 11, 2005	Supplement 23Labeling · Standard review	Approved	Letter Label
Oct 11, 2001	Supplement 19Labeling · Standard review	Approved	None posted
Jun 14, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 2, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 3, 1998	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 24, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 18, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 14, 1995	Supplement 13Manufacturing · Standard review	Approved	None posted
May 10, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 4, 1995	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 26, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 22, 1994	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 23, 1993	Supplement 5Labeling · Standard review	Approved	None posted
Nov 23, 1993	Supplement 4Labeling · Standard review	Approved	None posted
Jan 25, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 24, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19583
Drugs@FDA: Overview at FDA
Company: SmithKline Beecham

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters