Visitor Monitoring Drug History: VASOTEC
 
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Label and Approval History

Drug Name: VASOTEC
FDA Application No: (NDA) 019309
Active Ingredient(s): ENALAPRILAT
Company: BIOVAIL LABS INTL
 
Label History
 
View the label approved on June 29, 2004 for VASOTEC, (NDA) 019309


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
11/25/2002 027Manufacturing Change or Addition  
12/17/2001 026Control Supplement  
11/1/2002 025Labeling Revision Letter 
12/6/2000 024Control Supplement  
11/27/2001 023Labeling Revision Letter
Label
Review 
2/17/1999 022Labeling Revision Review 
6/11/1997 021Labeling Revision Review 
10/27/1997 020Labeling Revision  
9/28/1995 019Labeling Revision Review 
7/25/1994 018Labeling Revision Review 
2/18/1994 017Labeling Revision Review 
10/21/1993 016Labeling Revision Review 
5/11/1994 015Labeling Revision Review 
1/14/1994 014Labeling Revision Review 
2/24/1993 013Labeling Revision Review 
7/31/1996 012Labeling Revision Review 
9/30/1992 011Labeling Revision Review 
5/13/1992 010Labeling Revision  
5/7/1992 009Labeling Revision  
2/6/1991 008Labeling Revision  
1/29/1992 007Labeling Revision  
3/9/1990 006Labeling Revision  
11/30/1989 005Labeling Revision  
10/19/1989 004Labeling Revision  
4/18/1989 003Labeling Revision  
1/10/1989 001Labeling Revision  
2/9/1988 000Approval Other Important Information from FDA 
 
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