Drug History: ZYBAN

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:	ZYBAN
FDA Application No:	(NDA) 020711
Active Ingredient(s):	BUPROPION HYDROCHLORIDE
Company:	GLAXOSMITHKLINE

Label History

View the label approved on August 3, 2007 for ZYBAN, (NDA) 020711

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
8/2/2007	029	Labeling Revision	Letter Label
3/22/2007	028	Labeling Revision	Letter Label
11/16/2006	027	Labeling Revision	Letter Label
4/28/2006	024	Labeling Revision	Letter
3/13/2006	022	Labeling Revision	Letter
1/12/2005	021	Labeling Revision	Letter Label
11/3/2004	020	Labeling Revision	Letter Label
11/3/2004	019	Labeling Revision	Letter Label
2/14/2003	018	Labeling Revision	Letter Label
2/15/2002	017	Manufacturing Change or Addition
2/14/2003	016	Labeling Revision	Letter Label
2/21/2002	015	Labeling Revision	Letter Review
2/14/2003	014	Labeling Revision	Letter Label
2/14/2003	013	Labeling Revision	Letter Label
2/7/2001	012	Efficacy Supplement with Clinical Data to Support	Letter Label Review
8/3/2000	011	Control Supplement
11/28/2000	010	Labeling Revision
11/28/2000	009	Labeling Revision
11/28/2000	008	Labeling Revision
3/5/1999	007	Labeling Revision
4/7/1999	006	Package Change
3/5/1999	005	Labeling Revision
2/24/1999	004	Labeling Revision	Review
9/10/1999	003	New Dosage Regimen
2/24/1999	002	Labeling Revision	Review
9/10/1999	001	Comparative Efficacy Claim
5/14/1997	000	Approval	Review Other Important Information from FDA

Therapeutic Equivalents