Drug History: ZOFRAN

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:	ZOFRAN
FDA Application No:	(NDA) 020103
Active Ingredient(s):	ONDANSETRON HYDROCHLORIDE
Company:	GLAXOSMITHKLINE

Label History

View the label approved on August 23, 2006 for ZOFRAN, (NDA) 020103

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
8/22/2006	027	Labeling Revision	Letter Label
12/27/2005	025	Labeling Revision	Letter Label
2/18/2005	024	Control Supplement	Letter Label
11/24/2004	023	Labeling Revision	Letter Label
1/31/2003	021	Labeling Revision	Letter
10/24/2001	020	Control Supplement
10/24/2001	019	Package Change
12/13/2000	018	Labeling Revision	Letter Label
4/11/2000	017	Labeling Revision	Review
8/27/1999	016	Formulation Revision	Review
8/27/1999	015	New or Modified Indication	Letter Review
4/15/1997	013	Labeling Revision
11/16/1995	011	Labeling Revision
5/17/1995	010	Manufacturing Change or Addition
2/14/1995	009	Manufacturing Change or Addition
4/10/1995	008	New Dosage Regimen	Label
4/27/1994	007	Labeling Revision
4/15/1994	006	Manufacturing Change or Addition
4/19/1995	005	New or Modified Indication
9/26/1994	004	New or Modified Indication
4/4/1994	003	Labeling Revision
9/28/1993	002	Control Supplement
2/22/1993	001	Labeling Revision
12/31/1992	000	Approval

Therapeutic Equivalents