Drug History: TEMODAR

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:	TEMODAR
FDA Application No:	(NDA) 021029
Active Ingredient(s):	TEMOZOLOMIDE
Company:	SCHERING

Label History

View the label approved on October 23, 2006 for TEMODAR, (NDA) 021029

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
10/19/2006	012	Manufacturing Change or Addition	Letter Label
3/31/2006	011	Labeling Revision	Letter
4/22/2005	010	Labeling Revision	Letter
3/30/2005	009	Labeling Revision	Letter
3/15/2005	008	New or Modified Indication	Letter Label
6/29/2004	007	Labeling Revision	Letter
7/15/2004	006	Labeling Revision	Letter
3/11/2003	005	Efficacy Supplement with Clinical Data to Support	Letter Label
1/18/2002	004	Labeling Revision	Letter Label Review
3/5/2002	003	Control Supplement
5/18/2001	002	Control Supplement
6/9/2000	001	Control Supplement
8/11/1999	000	Approval	Letter Label Review Consumer Information Sheet

There are no Therapeutic Equivalents