Visitor Monitoring Drug History: FELBATOL
 
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Label and Approval History

Drug Name: FELBATOL
FDA Application No: (NDA) 020189
Active Ingredient(s): FELBAMATE
Company: MEDPOINTE
 
Label History
 
Labels are not available on this site for FELBATOL, (NDA) 020189
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/26/2002 019Manufacturing Change or Addition  
11/19/2002 018Labeling Revision Letter 
8/28/1995 012Control Supplement  
6/26/1995 011Control Supplement  
1/24/1995 010Expiration Date Change  
11/29/1994 009Labeling Revision  
11/1/1994 008Labeling Revision  
11/1/1994 006Labeling Revision  
5/31/1994 005Formulation Revision  
3/2/1994 004Labeling Revision  
12/21/1993 003Manufacturing Change or Addition  
12/20/1993 002Manufacturing Change or Addition  
9/17/1993 001Manufacturing Change or Addition  
7/29/1993 000Approval  
 
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