Visitor Monitoring Drug History: LOZOL
 
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Label and Approval History

Drug Name: LOZOL
FDA Application No: (NDA) 018538
Active Ingredient(s): INDAPAMIDE
Company: SANOFI AVENTIS US
 
Label History
 
Labels are not available on this site for LOZOL, (NDA) 018538
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/7/2000 027Manufacturing Change or Addition  
10/10/2000 026Labeling Revision  
12/11/1998 025Manufacturing Change or Addition  
1/27/1998 024Control Supplement  
2/26/1996 023Control Supplement  
5/16/1996 022Manufacturing Change or Addition  
10/29/1996 021Labeling Revision  
10/29/1996 020Labeling Revision  
3/31/1993 019Labeling Revision  
8/19/1993 018Control Supplement  
4/29/1993 017New Dosage Regimen  
6/24/1992 016Labeling Revision  
4/1/1992 015Manufacturing Change or Addition  
9/25/1991 014Labeling Revision  
6/23/1992 013Manufacturing Change or Addition  
3/8/1990 012Formulation Revision  
10/13/1989 011Formulation Revision  
7/10/1989 010Package Change  
1/3/1990 009Control Supplement  
2/23/1989 008Control Supplement  
11/29/1988 007Control Supplement  
11/9/1988 006Labeling Revision  
7/8/1988 005Expiration Date Change  
6/30/1987 004Control Supplement  
4/10/1984 003Manufacturing Change or Addition  
10/12/1983 002Package Change  
11/29/1983 001Control Supplement  
7/6/1983 000Approval  
 
Therapeutic Equivalents
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