Visitor Monitoring Drug History: NIZORAL
 
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: NIZORAL
FDA Application No: (NDA) 018533
Active Ingredient(s): KETOCONAZOLE
Company: JANSSEN PHARMA
 
Label History
 
Labels are not available on this site for NIZORAL, (NDA) 018533
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/13/2002 039Expiration Date Change  
4/1/2002 038Control Supplement  
9/17/1999 037Package Change  
4/13/1999 036Manufacturing Change or Addition  
7/24/1998 035Package Change  
5/28/1998 033Control Supplement  
3/17/1998 032Manufacturing Change or Addition  
6/14/1996 031Control Supplement  
4/8/1996 030Manufacturing Change or Addition  
7/8/1996 029Labeling Revision  
9/15/1995 028Manufacturing Change or Addition  
9/8/1995 026Manufacturing Change or Addition  
9/8/1995 025Control Supplement  
3/22/1994 024Labeling Revision  
9/20/1993 023Manufacturing Change or Addition  
12/28/1992 022Labeling Revision  
10/13/1992 021Manufacturing Change or Addition  
12/28/1992 020Labeling Revision  
3/15/1991 019Labeling Revision  
4/14/1989 018Labeling Revision  
7/8/1988 017Control Supplement  
5/10/1988 016Expiration Date Change  
6/19/1985 015Package Change  
6/30/1986 014Labeling Revision  
6/30/1986 013Labeling Revision  
6/30/1986 012Labeling Revision  
6/30/1986 011Labeling Revision  
7/9/1984 010Manufacturing Change or Addition  
7/9/1984 009Manufacturing Change or Addition  
9/8/1983 008Control Supplement  
4/15/1983 007Manufacturing Change or Addition  
4/15/1983 006Manufacturing Change or Addition  
6/23/1983 004Labeling Revision  
6/30/1986 003Labeling Revision  
6/23/1983 002Labeling Revision  
9/29/1981 001Manufacturing Change or Addition  
6/12/1981 000Approval  
 
Therapeutic Equivalents
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