Visitor Monitoring Drug History: VASERETIC
 
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: VASERETIC
FDA Application No: (NDA) 019221
Active Ingredient(s): ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
Company: BIOVAIL LABS INTL
 
Label History
 
View the label approved on November 27, 2001 for VASERETIC, (NDA) 019221


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
10/15/2002 029Manufacturing Change or Addition  
2/4/2002 028Manufacturing Change or Addition  
11/1/2002 027Labeling Revision Letter 
11/27/2001 026Labeling Revision Letter
Label
Review 
2/17/1999 025Labeling Revision Review 
10/13/1998 024Labeling Revision Review 
6/11/1997 023Labeling Revision Review 
7/12/1995 022Formulation Revision  
9/28/1995 021Labeling Revision  
7/25/1994 020Labeling Revision  
2/18/1994 019Labeling Revision  
10/21/1993 018Labeling Revision  
5/11/1994 017Labeling Revision  
1/14/1994 016Labeling Revision  
7/12/1995 015New Dosage Regimen  
2/24/1993 014Labeling Revision  
7/31/1996 013Labeling Revision  
9/30/1992 012Labeling Revision  
5/13/1992 011Labeling Revision  
5/7/1992 010Labeling Revision  
9/30/1992 009Package Change  
2/6/1991 007Labeling Revision  
3/9/1990 006Labeling Revision  
11/30/1989 005Labeling Revision  
12/22/1989 004Manufacturing Change or Addition  
4/18/1989 003Labeling Revision  
1/10/1989 002Labeling Revision  
1/30/1987 001Labeling Revision  
10/31/1986 000Approval  
 
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