For moderate blood loss. NDA 17609, held by Otsuka Icu Medcl. Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate.
As of Nov 13, 2026, NDA 17609 (Normosol-R And Dextrose 5% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Aug 13, 1975, with 98 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Normosol-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R and 5% Dextrose also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. The solution is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 13, 1975 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Normosol-R And Dextrose 5% In Plastic Container5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML · injectable;injection | Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2013 | Supplement 127Manufacturing · Standard review | Approved | None posted |
| Jun 20, 2000 | Supplement 107Labeling · Standard review | Approved | None posted |
| Jun 15, 2000 | Supplement 110Labeling · Standard review | Approved | None posted |
| Oct 29, 1998 | Supplement 109Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 108Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 103Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 102Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 106Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 105Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 98Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 99Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 94Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 95Manufacturing · Standard review | Approved | None posted |
| Jun 22, 1989 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 90Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 88Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 71Labeling | Approved | None posted |
| Oct 29, 1985 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 82Labeling | Approved | None posted |
| Sep 26, 1985 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| May 14, 1985 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Nov 16, 1984 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Nov 16, 1984 | Supplement 80Labeling | Approved | None posted |
| Nov 9, 1984 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 59Labeling | Approved | None posted |
| Apr 9, 1984 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1983 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1983 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 47Labeling | Approved | None posted |
| Jun 18, 1982 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1981 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 48Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 45Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1981 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1980 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1980 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 40Labeling | Approved | None posted |
| Jan 22, 1980 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1979 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1979 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1979 | Supplement 33Labeling | Approved | None posted |
| Mar 29, 1979 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1979 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1979 | Supplement 31 | Approved | None posted |
| Jan 5, 1979 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Dec 29, 1978 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1978 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 11, 1978 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1978 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1978 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| May 1, 1978 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1978 | Supplement 18Labeling | Approved | None posted |
| Jan 23, 1978 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1977 | Supplement 13Labeling | Approved | None posted |
| May 20, 1977 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1977 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 24, 1976 | Supplement 9Labeling | Approved | None posted |
| Nov 8, 1976 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 17, 1976 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1975 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1975 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1975 | Supplement 4Labeling | Approved | None posted |
| Oct 15, 1975 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1975 | Original applicationNew formulation or manufacturer · Standard 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
