Visitor Monitoring Drug History: ISOPTIN
 
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Label and Approval History

Drug Name: ISOPTIN
FDA Application No: (NDA) 018485
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
Company: FSC
 
Label History
 
Labels are not available on this site for ISOPTIN, (NDA) 018485
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/11/1998 010Manufacturing Change or Addition  
3/7/1994 009Labeling Revision  
9/16/1992 008Manufacturing Change or Addition  
10/8/1986 007Labeling Revision  
12/18/1985 006Control Supplement  
8/21/1984 005Package Change  
6/16/1987 004Package Change  
4/12/1984 003Control Supplement  
4/12/1984 002Manufacturing Change or Addition  
8/12/1981 000Approval  
 
Therapeutic Equivalents
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