Visitor Monitoring Drug History: DYMELOR
 
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Label and Approval History

Drug Name: DYMELOR
FDA Application No: (NDA) 013378
Active Ingredient(s): ACETOHEXAMIDE
Company: LILLY
 
Label History
 
Labels are not available on this site for DYMELOR, (NDA) 013378
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/19/1998 032Manufacturing Change or Addition  
6/16/1998 031Package Change  
11/27/1990 030Labeling Revision  
12/29/1988 029Labeling Revision  
1/30/1987 028Labeling Revision  
9/15/1986 027Control Supplement  
5/2/1986 026Labeling Revision  
3/18/1986 025Control Supplement  
2/14/1985 024Labeling Revision  
1/31/1983 022Control Supplement  
10/14/1980 019Formulation Revision  
2/23/1981 018Labeling Revision  
3/21/1980 017Manufacturing Change or Addition  
11/27/1979 016Control Supplement  
1/9/1979 015Labeling Revision  
9/15/1976 014Package Change  
7/21/1976 013Control Supplement  
12/23/1964 000Approval  
 
Therapeutic Equivalents
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