Visitor Monitoring Drug History: LUDIOMIL
 
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Label and Approval History

Drug Name: LUDIOMIL
FDA Application No: (NDA) 017543
Active Ingredient(s): MAPROTILINE HYDROCHLORIDE
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for LUDIOMIL, (NDA) 017543
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/10/1997 030Labeling Revision  
4/10/1997 029Labeling Revision  
3/5/1996 028Manufacturing Change or Addition  
11/28/1994 027Control Supplement  
4/10/1997 026Labeling Revision  
7/12/1993 025Control Supplement  
6/28/1994 024Control Supplement  
3/27/1990 022Manufacturing Change or Addition  
4/10/1997 021Labeling Revision  
4/7/1989 020Package Change  
4/10/1997 019Labeling Revision  
4/10/1997 018Labeling Revision  
3/21/1985 017Control Supplement  
4/26/1985 016Labeling Revision  
11/4/1983 015Control Supplement  
6/16/1983 014Labeling Revision  
11/17/1982 012Labeling Revision  
11/8/1982 011Labeling Revision  
10/21/1982 010Package Change  
1/12/1983 009Labeling Revision  
8/3/1981 008Package Change  
8/3/1981 007Package Change  
8/3/1981 006Package Change  
8/3/1981 005Package Change  
8/3/1981 004Labeling Revision  
9/30/1982 002Formulation Revision  
5/29/1981 001General Efficacy (MarkIV)  
12/1/1980 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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