Visitor Monitoring Drug History: VASOTEC
 
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Label and Approval History

Drug Name: VASOTEC
FDA Application No: (NDA) 018998
Active Ingredient(s): ENALAPRIL MALEATE
Company: BIOVAIL LABS INTL
 
Label History
 
View the label approved on February 13, 2001 for VASOTEC, (NDA) 018998


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
10/10/2002 064Manufacturing Change or Addition Review 
8/30/2002 063Manufacturing Change or Addition Letter 
4/3/2002 062Control Supplement Review 
2/4/2002 061Manufacturing Change or Addition Review 
2/13/2001 059Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
11/27/2001 058Labeling Revision Letter
Label
Review 
2/17/1999 057Labeling Revision Review 
12/10/1997 056Control Supplement  
7/21/1997 055Manufacturing Change or Addition  
7/23/1997 054Package Change  
6/11/1997 053Labeling Revision Review 
2/3/1997 052Manufacturing Change or Addition Review 
1/9/1997 051Manufacturing Change or Addition Review 
3/22/1996 050Manufacturing Change or Addition Review 
9/19/1995 049Control Supplement  
9/19/1995 048Control Supplement  
9/19/1995 047Control Supplement  
9/28/1995 046Labeling Revision Review 
7/25/1994 045Labeling Revision Review 
5/16/1994 044Labeling Revision  
2/18/1994 043Labeling Revision  
7/15/1994 042Control Supplement Review 
12/12/1994 041Manufacturing Change or Addition Review 
10/21/1993 040Labeling Revision  
1/14/1994 039Labeling Revision  
5/11/1994 038Labeling Revision  
7/1/1993 037Labeling Revision  
2/24/1993 036Labeling Revision  
7/26/1993 035Manufacturing Change or Addition  
7/31/1996 034Labeling Revision Review 
9/30/1992 033Labeling Revision  
11/4/1993 032New or Modified Indication  
5/7/1992 031Labeling Revision  
5/13/1992 030Labeling Revision  
9/30/1992 029Package Change  
4/8/1992 027Patient Population Altered  
8/2/1991 026Package Change  
2/6/1991 025Labeling Revision Review 
11/28/1990 024Labeling Revision Review 
7/19/1990 023Package Change Review 
6/12/1990 022New or Modified Indication Review 
3/9/1990 021Labeling Revision Review 
11/30/1989 020Labeling Revision Review 
4/18/1989 018Labeling Revision Review 
2/20/1991 017Manufacturing Change or Addition Review 
1/10/1989 016Labeling Revision  
3/29/1989 015Labeling Revision Review 
8/3/1988 013Manufacturing Change or Addition  
7/26/1988 012Formulation Revision  
4/25/1988 011Labeling Revision  
7/10/1987 009Package Change Review 
6/24/1988 007New or Modified Indication  
1/28/1987 006Labeling Revision Review 
5/14/1987 005Labeling Revision Review 
10/3/1986 004Labeling Revision  
11/7/1986 003Control Supplement  
10/27/1986 002Control Supplement  
12/24/1985 000Approval Review
Other Important Information from FDA 
 
Therapeutic Equivalents
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