Visitor Monitoring Drug History: SERENTIL
 
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Label and Approval History

Drug Name: SERENTIL
FDA Application No: (NDA) 016775
Active Ingredient(s): MESORIDAZINE BESYLATE
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for SERENTIL, (NDA) 016775
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/28/2001 042Manufacturing Change or Addition  
3/15/2001 041Labeling Revision Letter
Review 
9/6/2000 040Labeling Revision  
3/14/1997 039Control Supplement  
8/1/1994 036Control Supplement  
9/22/1989 032Manufacturing Change or Addition  
8/15/1989 031Manufacturing Change or Addition  
11/21/1988 029Manufacturing Change or Addition  
5/10/1989 028Control Supplement  
8/20/1987 022Control Supplement  
5/26/1987 021Control Supplement  
4/23/1987 020Control Supplement  
11/24/1986 019Control Supplement  
6/10/1986 017Control Supplement  
6/26/1984 015Control Supplement  
10/18/1982 014Control Supplement  
11/5/1982 013Labeling Revision  
11/16/1982 012Control Supplement  
6/19/1981 011Manufacturing Change or Addition  
12/10/1980 009Labeling Revision  
1/16/1980 008Manufacturing Change or Addition  
8/30/1979 007Package Change  
8/5/1977 006Package Change  
8/19/1977 005Package Change  
3/31/1975 004Labeling Revision  
3/31/1975 003Control Supplement  
2/27/1970 000Approval  
 
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