Visitor Monitoring Drug History: ZOLADEX
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: ZOLADEX
FDA Application No: (NDA) 019726
Active Ingredient(s): GOSERELIN ACETATE
Company: ASTRAZENECA
 
Label History
 
View the label approved on July 27, 1998 for ZOLADEX, (NDA) 019726


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 DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/19/2005 046Labeling Revision Letter 
6/24/2004 042Labeling Revision Letter 
9/13/2002 038Manufacturing Change or Addition  
2/28/2002 037Labeling Revision Letter 
1/29/2002 036Manufacturing Change or Addition  
2/5/2002 034Labeling Revision Letter
Review 
10/16/2000 033Control Supplement  
12/10/1999 031Manufacturing Change or Addition  
11/3/1999 030Labeling Revision  
1/20/1999 028Manufacturing Change or Addition  
12/7/1998 027Manufacturing Change or Addition  
9/18/1998 026Manufacturing Change or Addition  
7/27/1998 024New or Modified Indication Letter
Label
Review 
11/13/1997 023Control Supplement  
4/9/1998 022New or Modified Indication Review 
8/20/1997 021Control Supplement  
6/9/1997 020Control Supplement  
2/4/1997 019Labeling Revision  
6/27/1997 018New or Modified Indication Review 
12/18/1995 017Labeling Revision  
2/14/1996 016Control Supplement  
5/12/1995 015Control Supplement  
10/31/1994 013Control Supplement  
4/7/1994 012Control Supplement  
1/6/1994 011Labeling Revision  
1/6/1994 010Control Supplement  
3/29/1994 008Labeling Revision  
4/28/1992 007Labeling Revision  
2/2/1993 005New or Modified Indication  
8/15/1991 003Control Supplement  
2/26/1991 002Labeling Revision  
1/17/1991 001Control Supplement  
12/29/1989 000Approval  
 
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