Visitor Monitoring Drug History: LAMISIL
 
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Label and Approval History

Drug Name: LAMISIL
FDA Application No: (NDA) 020539
Active Ingredient(s): TERBINAFINE HYDROCHLORIDE
Company: NOVARTIS
 
Label History
 
View the label approved on February 3, 2004 for LAMISIL, (NDA) 020539


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/21/2004 012Labeling Revision Letter
Label 
12/27/2001 011Manufacturing Change or Addition  
4/13/2001 010Labeling Revision Letter 
4/30/2001 009Control Supplement  
2/1/2000 008Manufacturing Change or Addition  
4/21/1999 005Package Change  
1/5/1999 003Efficacy Supplement with Clinical Data to Support  
10/4/1996 002Manufacturing Change or Addition  
12/6/1996 001Control Supplement  
5/10/1996 000Approval Letter 
 
Therapeutic Equivalents
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