Drug History: GLEEVEC

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:	GLEEVEC
FDA Application No:	(NDA) 021335
Active Ingredient(s):	IMATINIB MESYLATE
Company:	NOVARTIS

Label History

View the label approved on December 20, 2002 for GLEEVEC, (NDA) 021335

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
10/31/2003	006	Labeling Revision	Letter Review
12/20/2002	004	New or Modified Indication	Letter Label Review
5/20/2003	003	Patient Population Altered	Letter Label Review
1/22/2002	002	Manufacturing Change or Addition	Label
2/1/2002	001	New or Modified Indication	Letter Label Review
5/10/2001	000	Approval	Letter Label Review Other Important Information from FDA

There are no Therapeutic Equivalents