Visitor Monitoring Drug History: HEPATOLITE
 
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: HEPATOLITE
FDA Application No: (NDA) 018467
Active Ingredient(s): TECHNETIUM TC-99M DISOFENIN KIT
Company: CIS
 
Label History
 
Labels are not available on this site for HEPATOLITE, (NDA) 018467
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/16/2002 018Manufacturing Change or Addition  
3/15/2000 017Manufacturing Change or Addition  
2/7/2000 016Manufacturing Change or Addition  
11/5/1997 015Manufacturing Change or Addition  
12/29/1993 014New or Modified Indication Review 
12/29/1993 013Labeling Revision Review 
5/2/1989 012Manufacturing Change or Addition  
5/19/1989 011Manufacturing Change or Addition  
5/19/1989 010Labeling Revision  
5/19/1989 009New or Modified Indication  
5/19/1989 007Manufacturing Change or Addition  
2/28/1986 005Control Supplement  
4/21/1983 003Control Supplement  
6/7/1983 002Labeling Revision  
4/26/1983 001Manufacturing Change or Addition  
3/16/1982 000Approval  
 
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