Drug History: GLIADEL

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:	GLIADEL
FDA Application No:	(NDA) 020637
Active Ingredient(s):	CARMUSTINE
Company:	MGI PHARMA INC

Label History

View the label approved on March 5, 2003 for GLIADEL, (NDA) 020637

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
12/27/2006	022	Labeling Revision	Letter
11/7/2001	017	Manufacturing Change or Addition
2/25/2003	016	New or Modified Indication	Letter Label Review
5/15/2001	015	Manufacturing Change or Addition
8/8/2000	014	Control Supplement
10/25/1999	013	Manufacturing Change or Addition
7/16/1999	012	Control Supplement
9/27/2000	011	Control Supplement
3/25/1999	010	Control Supplement
2/10/1999	009	Manufacturing Change or Addition
10/16/1998	008	Control Supplement
2/12/1998	007	Control Supplement
1/22/1998	006	Control Supplement
8/22/1997	004	Control Supplement
9/15/1997	003	Control Supplement
4/4/1997	002	Control Supplement
10/8/1996	001	Manufacturing Change or Addition
9/23/1996	000	Approval	Label

There are no Therapeutic Equivalents