For moderate blood loss. NDA 17586, held by Otsuka Icu Medcl. Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate.
As of Nov 13, 2026, NDA 17586 (Normosol-R In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Aug 13, 1975, with 96 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R pH 7.4 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. Normosol-R pH 7.4 is particularly valuable as a solution for use in starting blood, i.e., as a priming solution for the infusion set. No hemolysis of blood is seen at the interface or with mixed solution and blood.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 13, 1975 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Normosol-R In Plastic Container30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML · injectable;injection | Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2016 | Supplement 129Manufacturing · Standard review | Approved | None posted |
| Sep 5, 2013 | Supplement 127Manufacturing · Standard review | Approved | None posted |
| Jun 15, 2000 | Supplement 107Labeling · Standard review | Approved | None posted |
| Oct 29, 1998 | Supplement 106Manufacturing · Standard review | Approved | None posted |
| May 12, 1998 | Supplement 103Labeling · Standard review | Approved | None posted |
| Feb 12, 1998 | Supplement 105Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 100Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 99Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 102Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 101Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 95Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 94Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 92Manufacturing · Standard review | Approved | None posted |
| Jun 22, 1989 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 88Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1986 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 69Labeling | Approved | None posted |
| Oct 29, 1985 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 78Labeling | Approved | None posted |
| Sep 26, 1985 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| May 14, 1985 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1984 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 58Labeling | Approved | None posted |
| Apr 9, 1984 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Jan 17, 1984 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jan 17, 1984 | Supplement 60Labeling | Approved | None posted |
| Dec 8, 1983 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1983 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 46Labeling | Approved | None posted |
| Jun 18, 1982 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1981 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 45Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 47Labeling | Approved | None posted |
| Jan 7, 1981 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Sep 11, 1980 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1980 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 39Labeling | Approved | None posted |
| Jan 22, 1980 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1979 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1979 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1979 | Supplement 32Labeling | Approved | None posted |
| Feb 6, 1979 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1979 | Supplement 30 | Approved | None posted |
| Jan 5, 1979 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 29, 1978 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Oct 11, 1978 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1978 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1978 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1978 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Apr 11, 1978 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1978 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1978 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1978 | Supplement 18Labeling | Approved | None posted |
| Feb 8, 1978 | Supplement 19Labeling | Approved | None posted |
| Jan 23, 1978 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1977 | Supplement 13Labeling | Approved | None posted |
| May 20, 1977 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1977 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1977 | Supplement 8Labeling | Approved | None posted |
| Nov 8, 1976 | Supplement 5Manufacturing · 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 21, 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
