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) 019927
Active Ingredient(s): KETOCONAZOLE
Company: MCNEIL PED
 
Label History
 
Labels are not available on this site for NIZORAL, (NDA) 019927
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/2/2002 022Package Change  
5/6/2002 021Control Supplement  
2/28/2002 020Control Supplement  
2/1/1999 019Package Change  
5/26/1998 018Package Change  
5/26/1998 016Control Supplement  
2/9/1998 015Control Supplement  
10/10/1997 014Labeling Revision  
7/9/1996 013Control Supplement  
5/30/1997 012New or Modified Indication  
4/25/1996 011Labeling Revision  
11/2/1995 010Manufacturing Change or Addition  
2/8/1996 009Manufacturing Change or Addition  
11/2/1995 008Manufacturing Change or Addition  
10/26/1995 007Manufacturing Change or Addition  
11/2/1995 006Control Supplement  
10/7/1993 005Manufacturing Change or Addition  
7/2/1993 004Control Supplement  
9/11/1992 003Manufacturing Change or Addition  
3/6/1995 002Labeling Revision  
10/5/1990 001Formulation Revision  
8/31/1990 000Approval  
 
Therapeutic Equivalents
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