Drug History: EPIVIR

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:	EPIVIR
FDA Application No:	(NDA) 020596
Active Ingredient(s):	LAMIVUDINE
Company:	GLAXOSMITHKLINE

Label History

View the label approved on October 26, 2006 for EPIVIR, (NDA) 020596

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
10/25/2006	027	Labeling Revision	Letter Label
6/13/2006	025	Labeling Revision	Letter Label Review
9/29/2004	022	Labeling Revision	Letter Label
11/22/2004	021	Approval	Letter Label Review
11/13/2003	020	Labeling Revision	Letter Label
12/24/2002	019	Manufacturing Change or Addition	Review
9/13/2002	018	Manufacturing Change or Addition
3/1/2002	017	Labeling Revision	Letter
6/24/2002	016	New Dosage Regimen	Letter Label
10/8/2002	015	Labeling Revision	Letter Label
6/19/2001	014	Labeling Revision
3/6/2001	013	Labeling Revision	Letter Review
1/5/2001	012	Labeling Revision
10/8/1999	011	Manufacturing Change or Addition
10/18/1999	010	Formulation Revision	Review
3/8/1999	009	Labeling Revision
3/8/1999	008	Labeling Revision
3/23/1999	007	Efficacy Supplement with Clinical Data to Support	Review
12/15/1997	006	Labeling Revision
2/3/1998	005	Manufacturing Change or Addition
12/15/1997	004	Labeling Revision
11/13/1997	003	Manufacturing Change or Addition
4/11/1997	002	New or Modified Indication
7/31/1996	001	Labeling Revision
11/17/1995	000	Approval

Therapeutic Equivalents