Visitor Monitoring Drug History: SERENTIL
 
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Label and Approval History

Drug Name: SERENTIL
FDA Application No: (NDA) 016774
Active Ingredient(s): MESORIDAZINE BESYLATE
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for SERENTIL, (NDA) 016774
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/28/2001 075Manufacturing Change or Addition  
7/6/2001 074Manufacturing Change or Addition  
3/15/2001 073Labeling Revision Letter
Review 
9/6/2000 072Labeling Revision  
3/14/1997 071Control Supplement  
11/22/1995 070Manufacturing Change or Addition  
10/17/1995 069Control Supplement  
8/1/1994 066Package Change  
11/30/1990 062Package Change  
7/1/1994 061Control Supplement  
11/3/1989 059Package Change  
8/15/1989 058Manufacturing Change or Addition  
5/10/1989 057Control Supplement  
3/14/1990 056Package Change  
8/20/1987 054Control Supplement  
5/26/1987 053Control Supplement  
4/23/1987 052Control Supplement  
3/24/1986 050Package Change  
10/23/1985 049Formulation Revision  
5/8/1985 047Manufacturing Change or Addition  
3/14/1984 046Package Change  
10/17/1986 045Control Supplement  
11/5/1982 043Labeling Revision  
1/19/1983 042Control Supplement  
6/22/1981 041Manufacturing Change or Addition  
3/24/1981 039Formulation Revision  
12/10/1980 038Labeling Revision  
3/7/1980 037Package Change  
1/16/1980 036Manufacturing Change or Addition  
4/4/1979 035Manufacturing Change or Addition  
8/30/1979 034Package Change  
6/12/1978 033Formulation Revision  
12/8/1978 032Package Change  
6/3/1977 031Control Supplement  
6/3/1977 030Control Supplement  
1/24/1978 029Package Change  
9/15/1976 028Distributor  
5/25/1976 027Formulation Revision  
8/3/1976 026Package Change  
7/16/1976 025Package Change  
12/2/1975 024Control Supplement  
7/1/1975 023Control Supplement  
5/6/1975 020Control Supplement  
3/31/1975 019Control Supplement  
6/7/1974 018Control Supplement  
1/30/1975 015Control Supplement  
2/27/1970 000Approval  
 
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