Visitor Monitoring Drug History: ZARONTIN
 
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Label and Approval History

Drug Name: ZARONTIN
FDA Application No: (NDA) 012380
Active Ingredient(s): ETHOSUXIMIDE
Company: PARKE DAVIS
 
Label History
 
Labels are not available on this site for ZARONTIN, (NDA) 012380
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/1/2006 030Labeling Revision Letter 
4/19/2002 029Labeling Revision Letter 
9/22/2000 028Manufacturing Change or Addition  
6/28/2000 027Manufacturing Change or Addition  
4/9/2001 025Labeling Revision Letter 
2/22/1996 024Control Supplement  
4/9/2001 023Labeling Revision Letter 
4/9/2001 022Labeling Revision Letter 
1/8/1991 021Manufacturing Change or Addition  
7/31/1984 020Control Supplement  
11/8/1983 019Package Change  
9/3/1982 018Formulation Revision  
12/9/1981 017Manufacturing Change or Addition  
5/28/1981 016Manufacturing Change or Addition  
5/28/1981 015Formulation Revision  
2/3/1981 014Manufacturing Change or Addition  
12/11/1980 012Manufacturing Change or Addition  
6/2/1980 011Control Supplement  
11/2/1960 000Approval  
 
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