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) 019084
Active Ingredient(s): KETOCONAZOLE
Company: JANSSEN PHARMA
 
Label History
 
Labels are not available on this site for NIZORAL, (NDA) 019084
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/2/2002 031Control Supplement  
3/8/2002 030Control Supplement  
12/30/1999 028Package Change  
12/4/1998 027Manufacturing Change or Addition  
5/26/1998 026Package Change  
5/26/1998 024Control Supplement  
2/9/1998 023Control Supplement  
10/8/1996 021Control Supplement  
7/9/1996 020Control Supplement  
4/16/1996 019Labeling Revision  
11/17/1995 018Control Supplement  
11/17/1995 017Manufacturing Change or Addition  
11/2/1995 016Control Supplement  
11/2/1995 015Manufacturing Change or Addition  
11/2/1995 014Manufacturing Change or Addition  
11/2/1995 013Control Supplement  
10/7/1993 012Manufacturing Change or Addition  
1/28/1993 011Manufacturing Change or Addition  
1/28/1993 010Manufacturing Change or Addition  
1/27/1993 009New or Modified Indication  
10/12/1990 008Package Change  
1/31/1990 007Manufacturing Change or Addition  
11/14/1988 006Labeling Revision  
11/3/1987 005Control Supplement  
11/1/1988 004Manufacturing Change or Addition  
7/28/1987 003Expiration Date Change  
7/28/1987 002Manufacturing Change or Addition  
10/17/1988 001Labeling Revision  
12/31/1985 000Approval  
 
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