Visitor Monitoring Drug History: ARAVA
 
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: ARAVA
FDA Application No: (NDA) 020905
Active Ingredient(s): LEFLUNOMIDE
Company: SANOFI AVENTIS US
 
Label History
 
View the label approved on October 25, 2005 for ARAVA, (NDA) 020905


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 015Labeling Revision Letter
Label 
11/22/2004 014Labeling Revision Letter
Label 
3/5/2004 012Patient Population Altered Letter
Label 
6/13/2003 007Labeling Revision Letter
Label 
6/13/2003 006New or Modified Indication Letter
Label 
9/21/2000 005Control Supplement  
2/23/2000 004Labeling Revision  
2/23/2000 003Labeling Revision  
7/20/1999 002Package Change  
12/11/1998 001Manufacturing Change or Addition  
9/10/1998 000Approval Letter
Label
Review
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