Visitor Monitoring Drug History: LANOXICAPS
 
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Label and Approval History

Drug Name: LANOXICAPS
FDA Application No: (NDA) 018118
Active Ingredient(s): DIGOXIN
Company: SMITHKLINE BEECHAM
 
Label History
 
Labels are not available on this site for LANOXICAPS, (NDA) 018118
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/28/1998 017Manufacturing Change or Addition  
7/15/1998 016Labeling Revision Review 
6/25/1996 015Labeling Revision  
4/28/1994 014Labeling Revision  
5/5/1994 013Package Change  
8/6/1993 012Control Supplement  
5/7/1992 011Labeling Revision  
1/31/1989 010Labeling Revision  
5/22/1987 009Labeling Revision  
9/4/1986 008Control Supplement  
6/18/1984 007Control Supplement  
8/12/1986 006Labeling Revision  
5/10/1984 005Package Change  
1/5/1984 004Expiration Date Change  
8/12/1986 003Labeling Revision  
9/24/1984 002General Efficacy (MarkIV)  
1/9/1984 001Package Change  
7/26/1982 000Approval Review 
 
There are no Therapeutic Equivalents
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