NDA 17610, held by Otsuka Icu Medcl. Dextrose; Magnesium Acetate; Potassium Acetate; Sodium Chloride.
As of Nov 13, 2026, NDA 17610 (Normosol-M And Dextrose 5% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Aug 13, 1975, with 93 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 13, 1975 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Normosol-M And Dextrose 5% In Plastic Container5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML · injectable;injection | Dextrose; Magnesium Acetate; Potassium Acetate; Sodium Chloride | Rx |
| Sep 8, 2014 | Supplement 119Manufacturing · Standard review | Approved | None posted |
| Jul 29, 1999 | Supplement 102Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 103Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 98Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 101Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 100Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 99Manufacturing · Standard review | Approved | None posted |
| Aug 9, 1994 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 93Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 92Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 94Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 90Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 81Manufacturing · 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 75Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 79Labeling | Approved | None posted |
| Sep 26, 1985 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Nov 16, 1984 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| Nov 16, 1984 | Supplement 77Labeling | Approved | None posted |
| Oct 22, 1984 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 62Manufacturing · 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 64Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1983 | Supplement 63Manufacturing · 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 53Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1982 | Supplement 47Labeling | 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 44Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 45Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 48Labeling | 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 34Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 35Manufacturing · 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 |
| Feb 6, 1979 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1979 | Supplement 31Manufacturing · Standard review | 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 26Manufacturing · 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 23Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1978 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1978 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1978 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1978 | Supplement 20Labeling | Approved | None posted |
| Jan 23, 1978 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1977 | Supplement 16Labeling | Approved | None posted |
| May 20, 1977 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1977 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1977 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 13, 1977 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1976 | Supplement 10Labeling | 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
