Visitor Monitoring Drug History: DIFLUCAN
 
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: DIFLUCAN
FDA Application No: (NDA) 019949
Active Ingredient(s): FLUCONAZOLE
Company: PFIZER
 
Label History
 
View the label approved on April 5, 2004 for DIFLUCAN, (NDA) 019949


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
3/24/2004 037Labeling Revision Letter
Label 
10/7/2004 035Labeling Revision Letter
Label 
8/7/2002 033Labeling Revision Letter
Label 
10/7/2004 032Labeling Revision Letter
Label 
3/5/2001 031Control Supplement  
10/7/2004 030Labeling Revision Letter
Label 
3/1/2000 029Package Change  
9/27/1999 028Manufacturing Change or Addition  
2/22/1999 027Labeling Revision  
2/18/1998 026Control Supplement  
8/5/1997 025Labeling Revision  
2/19/1997 024Labeling Revision  
5/2/1997 023Package Change  
8/6/1996 022Labeling Revision  
7/23/1996 019Labeling Revision  
9/11/1995 018Manufacturing Change or Addition  
9/11/1995 017Manufacturing Change or Addition  
12/22/1995 016Control Supplement  
6/30/1994 015Labeling Revision  
5/24/1995 014Formulation Revision  
11/23/1994 012Patient Population Altered  
10/13/1993 008Labeling Revision  
6/14/1993 007Control Supplement  
10/13/1993 006Labeling Revision  
12/30/1993 003New or Modified Indication  
10/13/1993 002Labeling Revision  
8/20/1992 001Manufacturing Change or Addition  
1/29/1990 000Approval  
 
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