Visitor Monitoring Drug History: BUTISOL SODIUM
 
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Label and Approval History

Drug Name: BUTISOL SODIUM
FDA Application No: (NDA) 000793
Active Ingredient(s): BUTABARBITAL SODIUM
Company: MEDPOINTE PHARM HLC
 
Label History
 
View the label approved on October 4, 2007 for BUTISOL SODIUM, (NDA) 000793


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
9/28/2007 025Labeling Revision Letter
Label 
10/23/2002 024Manufacturing Change or Addition  
4/10/2000 023Manufacturing Change or Addition  
1/21/2000 022Manufacturing Change or Addition  
11/13/1998 021Manufacturing Change or Addition  
5/2/2000 020Labeling Revision  
11/2/1992 019Manufacturing Change or Addition  
1/14/1993 018Manufacturing Change or Addition  
1/15/1987 017Control Supplement  
9/26/1986 016Control Supplement  
11/4/1998 015Labeling Revision  
2/29/1984 014Manufacturing Change or Addition  
6/15/1984 013Package Change  
11/22/1983 012Package Change  
11/22/1983 011Labeling Revision  
11/22/1983 010Manufacturing Change or Addition  
11/22/1983 009Manufacturing Change or Addition  
11/8/1982 008Labeling Revision  
2/26/1982 007Labeling Revision  
2/16/1979 006Labeling Revision  
2/16/1979 005Labeling Revision  
6/2/1978 004Manufacturing Change or Addition  
11/30/1976 003Formulation Revision  
6/5/1939 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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