Visitor Monitoring Drug History: ZIAGEN
 
Drugs Directory of False Positives 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: ZIAGEN
FDA Application No: (NDA) 020978
Active Ingredient(s): ABACAVIR SULFATE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on May 9, 2007 for ZIAGEN, (NDA) 020978


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
5/7/2007 019Labeling Revision Letter
Label 
8/11/2006 016Labeling Revision Letter
Label
Review 
7/26/2004 015Labeling Revision Letter
Label 
8/2/2004 014New Dosage Regimen Letter
Label
Review 
4/15/2004 013Accelerated Approval Letter
Label 
7/17/2003 012Labeling Revision Letter
Label 
8/14/2002 010Labeling Revision Letter
Label 
12/24/2002 009Manufacturing Change or Addition Review 
10/2/2002 008Labeling Revision Letter
Label 
6/4/2002 007Labeling Revision  
1/28/2002 006Labeling Revision Letter 
7/13/2001 005Control Supplement  
7/27/2000 004Labeling Revision  
12/15/2000 002Efficacy Supplement with Clinical Data to Support Review
Medication Guide 
4/20/2000 001Labeling Revision  
12/17/1998 000Approval Letter
Label
Review
Medication Guide
Consumer Information Sheet 
 
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