Visitor Monitoring Drug History: ACTIGALL
 
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: ACTIGALL
FDA Application No: (NDA) 019594
Active Ingredient(s): URSODIOL
Company: WATSON PHARMS
 
Label History
 
Labels are not available on this site for ACTIGALL, (NDA) 019594
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/14/2002 021Labeling Revision Letter 
4/22/1999 020Package Change  
4/19/1999 019Manufacturing Change or Addition  
6/5/1996 018Manufacturing Change or Addition  
9/15/1995 017Manufacturing Change or Addition  
3/29/1996 016New or Modified Indication  
3/15/2002 013Expiration Date Change  
4/24/1992 011Labeling Revision  
10/5/1990 010Labeling Revision  
10/4/1991 009Control Supplement  
5/19/1989 008Labeling Revision  
8/2/1989 007Control Supplement  
4/19/1989 006Package Change  
9/30/1988 005Package Change  
10/26/1988 004Formulation Revision  
7/8/1988 003Labeling Revision  
7/8/1988 002Package Change  
2/14/1989 001Manufacturing Change or Addition  
12/31/1987 000Approval  
 
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