Visitor Monitoring Drug History: EC-NAPROSYN
 
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: EC-NAPROSYN
FDA Application No: (NDA) 020067
Active Ingredient(s): NAPROXEN
Company: ROCHE PALO
 
Label History
 
View the label approved on September 26, 2007 for ECNAPROSYN, (NDA) 020067


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 014Labeling Revision Letter
Label 
4/19/2007 013Labeling Revision Letter 
1/24/2006 011Labeling Revision Letter
Label 
3/10/2006 010Labeling Revision Letter
Label 
2/22/2002 009Manufacturing Change or Addition  
11/9/2001 008Package Change  
11/10/2004 006Labeling Revision Letter
Label 
5/19/2003 005Labeling Revision Letter 
11/10/2004 004Labeling Revision Letter
Label 
7/9/1997 003Manufacturing Change or Addition  
6/28/1996 002Manufacturing Change or Addition  
12/6/1994 001Manufacturing Change or Addition  
10/14/1994 000Approval  
 
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