Visitor Monitoring Drug History: PRESAMINE
 
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Label and Approval History

Drug Name: PRESAMINE
FDA Application No: (NDA) 011836
Active Ingredient(s): IMIPRAMINE HYDROCHLORIDE
Company: SANOFI AVENTIS US
 
Label History
 
Labels are not available on this site for PRESAMINE, (NDA) 011836
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/30/1984 072Labeling Revision  
5/1/1984 071Labeling Revision  
5/4/1983 069Package Change  
3/20/1981 068Control Supplement  
5/20/1980 067Labeling Revision  
4/16/1980 066Manufacturing Change or Addition  
4/16/1980 065Package Change  
1/30/1980 064Package Change  
9/10/1979 063Package Change  
1/31/1980 062Manufacturing Change or Addition  
12/1/1978 061Labeling Revision  
1/29/1980 060Control Supplement  
1/29/1980 059Control Supplement  
4/5/1978 058Expiration Date Change  
3/21/1978 050Control Supplement  
3/21/1978 046Control Supplement  
3/16/1976 044Control Supplement  
3/10/1976 043Control Supplement  
12/1/1975 042Control Supplement  
12/1/1975 041Control Supplement  
10/22/1976 040Control Supplement  
6/3/1974 034Control Supplement  
4/16/1959 000Approval  
 
Therapeutic Equivalents
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