Visitor Monitoring Drug History: ANAPROX
 
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: ANAPROX
FDA Application No: (NDA) 018164
Active Ingredient(s): NAPROXEN SODIUM
Company: ROCHE PALO
 
Label History
 
View the label approved on September 26, 2007 for ANAPROX, (NDA) 018164


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
9/20/2007 058Labeling Revision Letter
Label 
4/19/2007 057Labeling Revision Letter 
1/24/2006 056Labeling Revision Letter
Label 
3/10/2006 055Labeling Revision Letter
Label 
2/22/2002 054Manufacturing Change or Addition  
11/9/2001 053Package Change  
12/8/2000 052Manufacturing Change or Addition  
11/10/2004 051Labeling Revision Letter
Label 
11/10/2004 050Labeling Revision Letter
Label 
4/14/2003 049Labeling Revision Letter 
9/6/1994 048Manufacturing Change or Addition  
2/8/1995 047Formulation Revision  
12/15/1993 046Labeling Revision  
8/12/1992 045Manufacturing Change or Addition  
5/8/1992 043Package Change  
10/2/1990 042Control Supplement  
9/30/1987 036New or Modified Indication  
9/30/1987 035New Dosage Regimen  
9/30/1987 034Labeling Revision  
6/10/1986 033Package Change  
9/24/1985 031Labeling Revision  
5/3/1985 028Manufacturing Change or Addition  
9/30/1987 026Formulation Revision  
4/29/1985 025Manufacturing Change or Addition  
9/9/1983 021Labeling Revision  
8/29/1986 020Control Supplement  
2/22/1983 018Control Supplement  
12/7/1982 017Labeling Revision  
12/7/1982 016Labeling Revision  
9/30/1987 015Labeling Revision  
4/23/1985 014Formulation Revision  
10/18/1982 013Control Supplement  
9/9/1983 012Labeling Revision  
4/22/1982 011Manufacturing Change or Addition  
4/22/1982 010Manufacturing Change or Addition  
4/22/1982 009Manufacturing Change or Addition  
5/10/1982 006Package Change  
1/7/1982 005Package Change  
1/7/1982 004Package Change  
10/13/1981 003Control Supplement  
10/13/1981 002Control Supplement  
4/13/1981 001Labeling Revision  
9/4/1980 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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