Visitor Monitoring Drug History: BUTISOL SODIUM
 
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Label and Approval History

Drug Name: BUTISOL SODIUM
FDA Application No: (ANDA) 085380
Active Ingredient(s): BUTABARBITAL SODIUM
Company: MEDPOINTE PHARM HLC
 
Label History
 
Labels are not available on this site for BUTISOL SODIUM, (ANDA) 085380
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/3/2000 028Supplier Addition  
10/29/1999 026Control Supplement  
4/14/1999 024Labeling  
3/13/1998 023Chemistry  
9/18/1992 022Chemistry  
5/13/1992 021Chemistry  
5/13/1992 020Chemistry  
4/3/1990 019Chemistry  
4/3/1990 018Chemistry  
4/3/1990 017Chemistry  
2/10/1987 016Chemistry  
5/24/1989 015SBA  
8/10/1987 015Chemistry  
3/21/1985 013Chemistry  
3/21/1985 012Chemistry  
12/8/1983 011Chemistry  
9/7/1983 010Chemistry  
9/7/1983 008Chemistry  
12/7/1982 005Chemistry  
4/10/1978 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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