Drug History: XENICAL

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:	XENICAL
FDA Application No:	(NDA) 020766
Active Ingredient(s):	ORLISTAT
Company:	HLR

Label History

View the label approved on January 8, 2007 for XENICAL, (NDA) 020766

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
1/5/2007	022	Labeling Revision	Letter Label
9/2/2005	021	Labeling Revision	Letter Label Review
7/9/2004	020	Labeling Revision	Letter Label
10/22/2004	019	Efficacy Supplement with Clinical Data to Support	Letter Label Review
12/12/2003	018	Patient Population Altered	Letter Label Review Other Important Information from FDA
2/27/2002	014	Manufacturing Change or Addition
3/8/2002	013	Manufacturing Change or Addition	Review
2/21/2002	012	Control Supplement
12/19/2001	011	Control Supplement
12/19/2001	010	Control Supplement
11/12/2001	009	Package Change	Review
6/25/2001	007	Labeling Revision	Label
1/29/2001	006	Package Change
1/9/2001	005	Control Supplement
4/6/2000	004	Labeling Revision
4/6/2000	003	Labeling Revision
8/31/1999	001	Labeling Revision
4/23/1999	000	Approval	Letter Label Review Consumer Information Sheet

There are no Therapeutic Equivalents