Visitor Monitoring Drug History: SERENTIL
 
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Label and Approval History

Drug Name: SERENTIL
FDA Application No: (NDA) 016997
Active Ingredient(s): MESORIDAZINE BESYLATE
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for SERENTIL, (NDA) 016997
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/15/2001 041Labeling Revision Letter
Review 
9/6/2000 040Labeling Revision  
3/14/1997 039Control Supplement  
1/25/1991 034Manufacturing Change or Addition  
8/15/1989 032Manufacturing Change or Addition  
5/10/1989 031Control Supplement  
8/20/1987 029Control Supplement  
5/26/1987 028Control Supplement  
6/9/1987 027Package Change  
4/23/1987 026Control Supplement  
6/9/1987 025Package Change  
1/28/1987 024Control Supplement  
11/24/1986 022Package Change  
11/24/1986 021Package Change  
11/24/1986 020Package Change  
11/24/1986 019Package Change  
6/10/1986 018Control Supplement  
5/29/1984 015Package Change  
11/5/1982 014Labeling Revision  
9/13/1982 013Manufacturing Change or Addition  
5/14/1981 012Package Change  
12/10/1980 010Labeling Revision  
1/16/1980 009Manufacturing Change or Addition  
5/13/1980 008Formulation Revision  
5/25/1976 007Formulation Revision  
9/2/1975 006Control Supplement  
3/31/1975 005Labeling Revision  
3/31/1975 003Control Supplement  
1/31/1972 000Approval  
 
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