Visitor Monitoring Drug History: FREAMINE III 8.5% W/ ELECTROLYTES
 
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Label and Approval History

Drug Name: FREAMINE III 8.5% W/ ELECTROLYTES
FDA Application No: (NDA) 016822
Active Ingredient(s): AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Company: B BRAUN
 
Label History
 
View the label approved on June 1, 2004 for FREAMINE III 8.5 W ELECTROLYTES, (NDA) 016822


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
5/27/2004 065Control Supplement Letter
Label 
6/20/2000 064Control Supplement  
4/12/2000 063Control Supplement  
5/4/1999 062Control Supplement  
6/14/1996 061Control Supplement  
9/13/1995 060Control Supplement  
10/28/1994 059Manufacturing Change or Addition  
6/8/1993 058Control Supplement  
9/28/1992 057Manufacturing Change or Addition  
12/11/1991 056Manufacturing Change or Addition  
4/11/1990 055Control Supplement  
1/13/1988 052Labeling Revision  
12/28/1987 051Labeling Revision  
7/9/1987 050Labeling Revision  
7/9/1987 049Labeling Revision  
10/8/1986 048Labeling Revision  
10/21/1985 047Labeling Revision  
10/21/1985 046Labeling Revision  
6/14/1985 045Control Supplement  
7/1/1988 044Labeling Revision  
7/1/1988 043Control Supplement  
9/8/1984 042Labeling Revision  
4/11/1988 041Labeling Revision  
4/11/1988 040Package Change  
10/15/1985 039Labeling Revision  
10/15/1985 038Control Supplement  
7/23/1985 037Labeling Revision  
7/23/1985 036Control Supplement  
6/29/1982 035Formulation Revision  
8/26/1982 034Control Supplement  
5/17/1983 033Labeling Revision  
5/17/1983 032Control Supplement  
5/3/1982 031Control Supplement  
4/25/1983 030Practioner Draft Labeling  
6/17/1982 029Control Supplement  
5/4/1981 028Control Supplement  
4/10/1981 027Control Supplement  
6/20/1981 026Labeling Revision  
6/20/1981 025Control Supplement  
11/7/1980 024Control Supplement  
12/9/1980 023Control Supplement  
6/25/1980 022Expiration Date Change  
8/7/1980 021Labeling Revision  
8/7/1980 020Control Supplement  
8/20/1980 019Control Supplement  
6/6/1980 018Control Supplement  
4/20/1980 017Control Supplement  
4/17/1980 016Labeling Revision  
4/17/1980 015Control Supplement  
8/18/1978 013Labeling Revision  
10/2/1978 012Labeling Revision  
10/2/1978 011Control Supplement  
7/19/1977 010Control Supplement  
9/1/1977 009Control Supplement  
5/26/1977 007General Efficacy (MarkIV)  
5/6/1977 006Labeling Revision  
1/23/1975 005Control Supplement  
9/24/1971 000Approval  
 
There are no Therapeutic Equivalents
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