Visitor Monitoring Drug History: HEPATAMINE 8%
 
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Label and Approval History

Drug Name: HEPATAMINE 8%
FDA Application No: (NDA) 018676
Active Ingredient(s): AMINO ACIDS
Company: B BRAUN
 
Label History
 
View the label approved on May 4, 2004 for HEPATAMINE 8, (NDA) 018676


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
4/29/2004 022Control Supplement Letter
Label 
6/20/2000 021Control Supplement  
4/11/2000 020Control Supplement  
6/14/1996 019Control Supplement  
10/28/1994 018Manufacturing Change or Addition  
6/8/1993 017Control Supplement  
9/28/1992 016Manufacturing Change or Addition  
12/11/1991 015Manufacturing Change or Addition  
4/11/1990 014Control Supplement  
1/13/1988 011Labeling Revision  
7/9/1987 010Labeling Revision  
11/13/1986 009Control Supplement  
10/3/1986 008Labeling Revision  
7/16/1985 007Labeling Revision  
4/10/1985 006Control Supplement  
10/3/1986 005Formulation Revision  
4/11/1988 004Labeling Revision  
3/11/1988 003Package Change  
12/13/1982 002Labeling Revision  
10/15/1982 001Control Supplement  
8/3/1982 000Approval  
 
Therapeutic Equivalents
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