Drug History: ZOLADEX

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:	ZOLADEX
FDA Application No:	(NDA) 020578
Active Ingredient(s):	GOSERELIN ACETATE
Company:	ASTRAZENECA

Label History

View the label approved on July 27, 1998 for ZOLADEX, (NDA) 020578

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
10/19/2005	025	Labeling Revision	Letter
6/24/2004	020	Labeling Revision	Letter
2/28/2002	016	Labeling Revision	Letter
2/5/2002	013	Labeling Revision	Letter
3/9/2001	012	Manufacturing Change or Addition
10/16/2000	011	Control Supplement
6/20/2000	010	Control Supplement
11/3/1999	009	Labeling Revision
3/4/1999	008	Manufacturing Change or Addition
12/7/1998	007	Manufacturing Change or Addition
9/18/1998	006	Manufacturing Change or Addition
7/16/1998	005	Manufacturing Change or Addition
11/13/1997	004	Control Supplement
7/27/1998	003	New or Modified Indication	Letter Label Review
6/9/1997	002	Control Supplement
4/14/1999	001	Labeling Revision
1/11/1996	000	Approval

There are no Therapeutic Equivalents