NDA 17799, held by Otsuka Icu Medcl. Dextrose; Sodium Chloride.
As of Nov 13, 2026, NDA 17799 (Dextrose 5% And Sodium Chloride 0.3% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Apr 12, 1977, with 95 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 |
|---|---|---|---|
| Apr 12, 1977 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;300MG/100ML · injectable;injection | Dextrose; Sodium Chloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2013 | Supplement 130Manufacturing · Standard review | Approved | None posted |
| Nov 18, 2002 | Supplement 107Manufacturing · Standard review | Approved | None posted |
| Mar 21, 2000 | Supplement 106Labeling · Standard review | Approved | None posted |
| Jun 8, 1999 | Supplement 105Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1998 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Aug 20, 1997 | Supplement 102Labeling · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 103Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 101Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 100Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 99Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 98Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 94Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 90Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1989 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 82Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 66Labeling | Approved | None posted |
| Oct 29, 1985 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 74Labeling | Approved | None posted |
| Sep 30, 1985 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1985 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 53Labeling | Approved | None posted |
| Jun 14, 1984 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1983 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1983 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1982 | Supplement 39Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1982 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1981 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1981 | Supplement 42Labeling | Approved | None posted |
| Oct 7, 1981 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 38Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 40Labeling | Approved | None posted |
| Jan 7, 1981 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1980 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 32Labeling | Approved | None posted |
| Feb 12, 1980 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1980 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1979 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1979 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1979 | Supplement 25Labeling | Approved | None posted |
| Feb 6, 1979 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1979 | Supplement 23 | Approved | None posted |
| Jan 5, 1979 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1978 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1978 | Supplement 22Labeling | Approved | None posted |
| Oct 11, 1978 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1978 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1978 | Supplement 7Labeling | Approved | None posted |
| Aug 15, 1978 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1978 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1978 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 8, 1978 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1978 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1978 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1978 | Supplement 11Labeling | Approved | None posted |
| Sep 28, 1977 | Supplement 5Labeling | Approved | None posted |
| Aug 15, 1977 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 12, 1977 | 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
