NDA 17606, held by Otsuka Icu Medcl. Dextrose; Sodium Chloride.
As of Nov 13, 2026, NDA 17606 (Dextrose 5% And Sodium Chloride 0.225% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Aug 13, 1975, with 102 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 13, 1975 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 5% And Sodium Chloride 0.225% In Plastic Container5GM/100ML;225MG/100ML · injectable;injection | Dextrose; Sodium Chloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2013 | Supplement 141Manufacturing · Standard review | Approved | None posted |
| Mar 21, 2000 | Supplement 116Labeling · Standard review | Approved | None posted |
| Oct 29, 1998 | Supplement 115Manufacturing · Standard review | Approved | None posted |
| Aug 20, 1997 | Supplement 113Labeling · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 114Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 112Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 108Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 107Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 111Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 110Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 109Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 105Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 101Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 100Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 102Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 98Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1988 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 94Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 93Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 92Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 77Labeling | Approved | None posted |
| Oct 29, 1985 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 85Labeling | Approved | None posted |
| Sep 30, 1985 | Supplement 90Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1985 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 64Labeling | Approved | None posted |
| Jun 14, 1984 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1983 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1983 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1982 | Supplement 50Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1982 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1981 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1981 | Supplement 53Labeling | Approved | None posted |
| Oct 7, 1981 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 49Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 51Labeling | Approved | None posted |
| Jan 7, 1981 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1980 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 43Labeling | Approved | None posted |
| Feb 12, 1980 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1980 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1979 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1979 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1979 | Supplement 36Labeling | Approved | None posted |
| Feb 6, 1979 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1979 | Supplement 34 | Approved | None posted |
| Jan 5, 1979 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1978 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1978 | Supplement 33Labeling | Approved | None posted |
| Oct 11, 1978 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1978 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1978 | Supplement 18Labeling | Approved | None posted |
| Aug 15, 1978 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1978 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1978 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 8, 1978 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Apr 11, 1978 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1978 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 13, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1978 | Supplement 21Labeling | Approved | None posted |
| Jan 23, 1978 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1977 | Supplement 15Labeling | Approved | None posted |
| May 20, 1977 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 9, 1977 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1977 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1976 | 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 22, 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
