Drug History: XELODA

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:	XELODA
FDA Application No:	(NDA) 020896
Active Ingredient(s):	CAPECITABINE
Company:	HLR

Label History

View the label approved on June 15, 2005 for XELODA, (NDA) 020896

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
6/15/2005	016	New or Modified Indication	Letter Label
3/15/2003	012	Labeling Revision	Letter Label
9/7/2001	011	Labeling Revision	Letter Label Review
9/7/2001	010	Accelerated Approval	Letter Label Review
4/30/2001	009	Labeling Revision	Letter Label Review
3/24/2000	007	Labeling Revision
4/30/2001	006	New or Modified Indication	Letter Label Review
8/17/1999	005	Control Supplement
4/2/1999	004	Labeling Revision
2/4/1999	003	Control Supplement
2/4/1999	002	Manufacturing Change or Addition
2/4/1999	001	Control Supplement
4/30/1998	000	Approval	Letter Label Review Consumer Information Sheet

There are no Therapeutic Equivalents