Visitor Monitoring Drug History: NAPROSYN
 
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: NAPROSYN
FDA Application No: (NDA) 017581
Active Ingredient(s): NAPROXEN
Company: ROCHE PALO
 
Label History
 
View the label approved on September 26, 2007 for NAPROSYN, (NDA) 017581


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 108Labeling Revision Letter
Label 
4/19/2007 107Labeling Revision Letter 
1/24/2006 106Labeling Revision Letter
Label 
3/10/2006 105Labeling Revision Letter
Label 
2/22/2002 103Manufacturing Change or Addition  
11/9/2001 102Package Change  
12/8/2000 101Manufacturing Change or Addition  
11/10/2004 100Labeling Revision Letter
Label 
11/10/2004 099Labeling Revision Letter
Label 
4/14/2003 098Labeling Revision Letter 
12/8/1994 097Manufacturing Change or Addition  
3/28/1994 096Package Change  
9/12/1994 095Control Supplement  
8/12/1992 093Manufacturing Change or Addition  
5/8/1992 089Package Change  
9/16/1991 088Package Change  
4/21/1994 087Package Change  
10/30/1991 086Control Supplement  
4/21/1989 080Formulation Revision  
3/23/1987 073New or Modified Indication  
12/16/1986 072Labeling Revision  
9/24/1985 069Labeling Revision  
6/10/1986 068Package Change  
7/17/1986 067Control Supplement  
3/23/1987 065New Dosage Regimen  
4/23/1985 064Manufacturing Change or Addition  
12/16/1986 063Formulation Revision  
4/23/1985 062Manufacturing Change or Addition  
4/29/1985 060Manufacturing Change or Addition  
9/9/1983 054Labeling Revision  
4/23/1985 053Control Supplement  
2/18/1988 051Manufacturing Change or Addition  
12/3/1982 050Labeling Revision  
12/3/1982 049Labeling Revision  
1/13/1983 048Control Supplement  
9/9/1983 046Labeling Revision  
3/31/1982 045Manufacturing Change or Addition  
3/31/1982 044Manufacturing Change or Addition  
12/21/1981 043Package Change  
1/7/1982 042Package Change  
10/13/1981 041Control Supplement  
10/13/1981 040Control Supplement  
10/13/1981 039Control Supplement  
1/8/1982 038Package Change  
4/2/1981 037Control Supplement  
10/13/1981 036Formulation Revision  
4/13/1981 034Labeling Revision  
10/13/1981 033Labeling Revision  
4/15/1982 031Labeling Revision  
9/12/1980 030Labeling Revision  
5/13/1980 027Labeling Revision  
3/21/1980 026Control Supplement  
4/14/1980 024Formulation Revision  
7/9/1979 020Control Supplement  
7/9/1979 019Package Change  
9/6/1979 018Manufacturing Change or Addition  
7/17/1979 017Control Supplement  
2/15/1979 015Control Supplement  
2/15/1979 013Control Supplement  
6/7/1979 012Manufacturing Change or Addition  
5/2/1978 011Manufacturing Change or Addition  
5/24/1979 010Control Supplement  
11/27/1978 009Control Supplement  
8/4/1978 007Control Supplement  
5/2/1979 006Package Change  
5/2/1979 005Package Change  
7/15/1980 004Manufacturing Change or Addition Review 
11/29/1976 003Manufacturing Change or Addition  
5/13/1976 002Labeling Revision  
7/15/1980 001General Efficacy (MarkIV)  
3/11/1976 000Approval  
 
Therapeutic Equivalents
©2019 Drugs That Causes a False Positive on a Drug Test