Visitor Monitoring Drug History: SUSTIVA
 
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: SUSTIVA
FDA Application No: (NDA) 020972
Active Ingredient(s): EFAVIRENZ
Company: BRISTOL MYERS SQUIBB
 
Label History
 
View the label approved on February 2, 2007 for SUSTIVA, (NDA) 020972


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
1/24/2007 029Labeling Revision Letter
Label 
3/28/2006 027Labeling Revision Letter
Label
Review 
4/20/2005 026Labeling Revision Letter
Label 
10/22/2004 024Labeling Revision Letter
Label 
8/13/2004 022Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
11/13/2003 021Labeling Revision Letter
Label 
6/10/2003 019Labeling Revision Letter
Label 
6/10/2003 018Labeling Revision Letter
Label 
9/20/2002 017Labeling Revision Letter 
1/29/2003 016Labeling Revision Letter
Label 
2/28/2002 014Manufacturing Change or Addition Review 
10/16/2001 013Labeling Revision Label 
11/21/2001 012Manufacturing Change or Addition  
5/16/2001 009Manufacturing Change or Addition  
4/12/2001 008Control Supplement  
3/1/2002 007Labeling Revision Letter 
11/14/2000 006Labeling Revision  
5/31/2000 005Manufacturing Change or Addition  
4/18/2000 004Control Supplement  
5/31/2000 003Manufacturing Change or Addition  
8/27/1999 002Expiration Date Change  
2/9/2000 001Accelerated Approval Letter
Label
Review 
9/17/1998 000Approval Letter
Label
Review
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