Visitor Monitoring Drug History: EFUDEX
 
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: EFUDEX
FDA Application No: (NDA) 016831
Active Ingredient(s): FLUOROURACIL
Company: VALEANT PHARM INTL
 
Label History
 
View the label approved on October 19, 2005 for EFUDEX, (NDA) 016831


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
5/10/2006 051Package Change Letter 
10/13/2005 049Labeling Revision Letter
Label 
6/24/2004 047Labeling Revision Letter
Label 
4/27/2004 046Manufacturing Change or Addition Letter 
11/27/2002 043Manufacturing Change or Addition  
8/30/2001 042Manufacturing Change or Addition  
7/3/2001 041Control Supplement  
7/3/2001 040Control Supplement  
2/12/2001 039Manufacturing Change or Addition  
6/20/2000 038Control Supplement  
7/7/2000 037Manufacturing Change or Addition  
7/7/2000 036Manufacturing Change or Addition  
4/5/2000 035Manufacturing Change or Addition  
11/2/1998 033Control Supplement  
2/18/1997 032Control Supplement  
8/5/1993 031Control Supplement  
3/4/1993 030Control Supplement  
3/21/1995 029Labeling Revision  
11/30/1988 028Manufacturing Change or Addition  
11/14/1986 027Manufacturing Change or Addition  
6/10/1985 026Package Change  
3/14/1985 025Control Supplement  
8/13/1984 024Control Supplement  
5/4/1984 023Control Supplement  
8/12/1983 022Control Supplement  
8/12/1983 021Control Supplement  
3/14/1983 020Control Supplement  
5/14/1982 019Control Supplement  
3/10/1982 018Labeling Revision  
3/26/1987 017Practioner Draft Labeling  
12/18/1979 016Control Supplement  
10/23/1979 015Control Supplement  
11/21/1978 014Manufacturing Change or Addition  
12/14/1977 013Control Supplement  
12/14/1977 012Control Supplement  
5/7/1975 011Control Supplement  
5/7/1975 010Control Supplement  
9/19/1974 009Control Supplement  
6/30/1975 008Control Supplement  
7/29/1970 000Approval  
 
Therapeutic Equivalents
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