NDA 16822, held by B Braun. Amino Acids, Amino Acids; Magnesium Acetate; Phosphoric Acid; Potassium Chloride; Sodium Acetate; Sodium Chloride, Amino Acids; Magnesium Acetate; Phosphoric Acid; Potassium Acetate; Potassium Chloride; Sodium Acetate.
As of Nov 13, 2026, NDA 16822 (Freamine 8.5%, Freamine Ii 8.5%, Freamine Iii 3% W/ Electrolytes), held by B Braun, was first approved by FDA on Sep 24, 1971, with 62 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 1977 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Sep 24, 1971 | Original applicationNew combination · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Freamine 8.5%8.5% (8.5GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Freamine Ii 8.5%8.5% (8.5GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Freamine Iii 3% W/ Electrolytes3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML · injectable;injection | Amino Acids; Magnesium Acetate; Phosphoric Acid; Potassium Chloride; Sodium Acetate; Sodium Chloride | Discontinued |
| Freamine Iii 8.5%8.5% (8.5GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Freamine Iii 10%10% (10GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Freamine Hbc 6.9%6.9% (6.9GM/100ML) · injectable;injection | Amino Acids | Discontinued |
| Freamine Iii 8.5% W/ Electrolytes8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML · injectable;injection | Amino Acids; Magnesium Acetate; Phosphoric Acid; Potassium Acetate; Potassium Chloride; Sodium Acetate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2014 | Supplement 72Manufacturing · Priority review | Approved | None posted |
| Nov 8, 2013 | Supplement 81Manufacturing · Priority review | Approved | None posted |
| Mar 19, 2013 | Supplement 74Manufacturing · Priority review | Approved | None posted |
| Mar 15, 2013 | Supplement 75Manufacturing · Priority review | Approved | None posted |
| Jan 9, 2013 | Supplement 77Manufacturing · Priority review | Approved | None posted |
| May 27, 2004 | Supplement 65Manufacturing · Priority review | Approved | |
| Jun 20, 2000 | Supplement 64Manufacturing · Priority review | Approved | None posted |
| Apr 12, 2000 | Supplement 63Manufacturing · Priority review | Approved | None posted |
| May 4, 1999 | Supplement 62Manufacturing · Priority review | Approved | None posted |
| Jun 14, 1996 | Supplement 61Manufacturing · Priority review | Approved | None posted |
| Sep 13, 1995 | Supplement 60Manufacturing · Priority review | Approved | None posted |
| Oct 28, 1994 | Supplement 59Manufacturing · Priority review | Approved | None posted |
| Jun 8, 1993 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Sep 28, 1992 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Dec 11, 1991 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Apr 11, 1990 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Jul 1, 1988 | Supplement 44Labeling | Approved | None posted |
| Jul 1, 1988 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Apr 11, 1988 | Supplement 41Labeling | Approved | None posted |
| Apr 11, 1988 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jan 13, 1988 | Supplement 52Labeling | Approved | None posted |
| Dec 28, 1987 | Supplement 51Labeling | Approved | None posted |
| Jul 9, 1987 | Supplement 50Labeling | Approved | None posted |
| Jul 9, 1987 | Supplement 49Labeling | Approved | None posted |
| Oct 8, 1986 | Supplement 48Labeling | Approved | None posted |
| Oct 21, 1985 | Supplement 47Labeling | Approved | None posted |
| Oct 21, 1985 | Supplement 46Labeling | Approved | None posted |
| Oct 15, 1985 | Supplement 39Labeling | Approved | None posted |
| Oct 15, 1985 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Jul 23, 1985 | Supplement 37Labeling | Approved | None posted |
| Jul 23, 1985 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jun 14, 1985 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Sep 8, 1984 | Supplement 42Labeling | Approved | None posted |
| May 17, 1983 | Supplement 33Labeling | Approved | None posted |
| May 17, 1983 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Apr 25, 1983 | Supplement 30Labeling | Approved | None posted |
| Aug 26, 1982 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Jun 29, 1982 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Jun 17, 1982 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| May 3, 1982 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Jun 20, 1981 | Supplement 26Labeling | Approved | None posted |
| Jun 20, 1981 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| May 4, 1981 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Apr 10, 1981 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Dec 9, 1980 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Nov 7, 1980 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Aug 20, 1980 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Aug 7, 1980 | Supplement 21Labeling | Approved | None posted |
| Aug 7, 1980 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Jun 25, 1980 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jun 6, 1980 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Apr 20, 1980 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Apr 17, 1980 | Supplement 16Labeling | Approved | None posted |
| Apr 17, 1980 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Oct 2, 1978 | Supplement 12Labeling | Approved | None posted |
| Oct 2, 1978 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Aug 18, 1978 | Supplement 13Labeling | Approved | None posted |
| Sep 1, 1977 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jul 19, 1977 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| May 26, 1977 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| May 6, 1977 | Supplement 6Labeling | Approved | None posted |
| Jan 23, 1975 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Sep 24, 1971 | Original applicationNew combination · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
