NDA 17585, held by Otsuka Icu Medcl. Dextrose; Sodium Chloride.
As of Nov 13, 2026, NDA 17585 (Dextrose 5% And Sodium Chloride 0.9% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Jan 7, 1976, with 104 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 |
|---|---|---|---|
| Jan 7, 1976 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;900MG/100ML · injectable;injection | Dextrose; Sodium Chloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2015 | Supplement 142Manufacturing · Standard review | Approved | None posted |
| Sep 8, 2014 | Supplement 140Manufacturing · Standard review | Approved | None posted |
| Jul 18, 2002 | Supplement 116Labeling | Approved | None posted |
| Mar 31, 1999 | Supplement 115Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 114Manufacturing · Standard review | Approved | None posted |
| Aug 20, 1997 | Supplement 112Labeling | Approved | None posted |
| Jun 11, 1997 | Supplement 113Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 111Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 107Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 106Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 110Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 109Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 108Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 100Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 99Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 101Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1989 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 93Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 92Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 88Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 76Labeling | Approved | None posted |
| Oct 29, 1985 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 82Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 84Labeling | Approved | None posted |
| Sep 30, 1985 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1985 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 90Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 83Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 63Labeling | Approved | None posted |
| Jun 14, 1984 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1983 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1983 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1982 | Supplement 49Labeling | Approved | None posted |
| Jul 26, 1982 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Feb 5, 1982 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1981 | Supplement 52Labeling | Approved | None posted |
| Oct 21, 1981 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1981 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 50Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 48Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1981 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1980 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 42Labeling | Approved | None posted |
| Feb 12, 1980 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1980 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1979 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1979 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1979 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1979 | Supplement 35Labeling | Approved | None posted |
| Feb 6, 1979 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1979 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1979 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1978 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1978 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1978 | Supplement 32Labeling | Approved | None posted |
| Oct 11, 1978 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1978 | Supplement 17Labeling | Approved | None posted |
| Aug 15, 1978 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1978 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jul 12, 1978 | Supplement 21Manufacturing · 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 18Manufacturing · Standard review | Approved | None posted |
| May 8, 1978 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1978 | Supplement 19Manufacturing · 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 12Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1977 | Supplement 15Labeling | Approved | None posted |
| May 20, 1977 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 3, 1977 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1977 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1976 | Supplement 8Labeling | Approved | None posted |
| May 3, 1976 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1976 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1976 | Supplement 2Labeling | Approved | None posted |
| Mar 3, 1976 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 3, 1976 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1976 | 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
