Drug History: RELAFEN

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Label and Approval History

Drug Name:	RELAFEN
FDA Application No:	(NDA) 019583
Active Ingredient(s):	NABUMETONE
Company:	SMITHKLINE BEECHAM

Label History

View the label approved on January 25, 2006 for RELAFEN, (NDA) 019583

To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.

Approval History

Action Date	Supplement Number	Approval Type	Letters, Reviews, Labels, Patient Package Insert
1/24/2006	025	Labeling Revision	Letter Label
8/11/2005	023	Labeling Revision	Letter Label
6/14/2001	020	Control Supplement
10/11/2001	019	Labeling Revision
8/2/1999	018	Manufacturing Change or Addition
2/3/1998	016	Manufacturing Change or Addition
7/24/1996	015	Manufacturing Change or Addition
6/18/1996	014	Control Supplement
7/14/1995	013	Control Supplement
5/10/1995	012	Control Supplement
1/4/1995	011	Control Supplement
10/26/1994	010	Manufacturing Change or Addition
9/22/1994	009	Control Supplement
11/23/1993	005	Labeling Revision
11/23/1993	004	Labeling Revision
1/25/1993	003	Manufacturing Change or Addition
12/24/1991	000	Approval

There are no Therapeutic Equivalents