Visitor Monitoring Drug History: ZYFLO
 
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: ZYFLO
FDA Application No: (NDA) 020471
Active Ingredient(s): ZILEUTON
Company: CRITICAL
 
Label History
 
View the label approved on September 30, 2005 for ZYFLO, (NDA) 020471


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
9/28/2005 011Manufacturing Change or Addition Letter
Label 
12/16/2002 009Labeling Revision Letter 
4/23/2001 008Labeling Revision  
9/4/1998 007Labeling Revision  
9/24/1998 006Package Change  
9/8/1997 005Control Supplement  
5/6/1997 004Control Supplement  
5/30/1997 003Manufacturing Change or Addition  
5/21/1997 001Control Supplement  
12/9/1996 000Approval  
 
There are no Therapeutic Equivalents
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