Visitor Monitoring Drug History: ALEVE
 
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: ALEVE
FDA Application No: (NDA) 020204
Active Ingredient(s): NAPROXEN SODIUM
Company: BAYER
 
Label History
 
View the label approved on May 5, 2005 for ALEVE, (NDA) 020204


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
1/5/2006 023Labeling Revision Letter 
5/4/2005 021Labeling Revision Letter
Label 
3/22/2004 019Labeling Revision Letter 
8/30/2002 016Manufacturing Change or Addition Letter 
12/21/2001 015Control Supplement  
3/27/2001 014Manufacturing Change or Addition  
1/3/2001 013Manufacturing Change or Addition  
6/7/2000 012Manufacturing Change or Addition  
5/11/2000 011Manufacturing Change or Addition  
8/23/2000 010Labeling Revision  
3/19/2002 008Labeling Revision Letter 
3/6/2001 007Labeling Revision Letter 
11/20/1998 006Package Change  
4/16/1998 005Formulation Revision  
8/1/1996 003Manufacturing Change or Addition  
2/10/1995 002Package Change  
8/12/1994 001Manufacturing Change or Addition  
1/11/1994 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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