NDA 17608, held by Otsuka Icu Medcl. Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate.
As of Nov 13, 2026, NDA 17608 (Dextrose 5% And Lactated Ringer'S In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Aug 13, 1975, with 105 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, 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 Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 24, 2015 | Supplement 140Manufacturing · Standard review | Approved | None posted |
| Sep 8, 2014 | Supplement 137Manufacturing · Standard review | Approved | None posted |
| Aug 15, 2014 | Supplement 139Manufacturing · Standard review | Approved | None posted |
| Oct 28, 1999 | Supplement 116Labeling | Approved | None posted |
| Oct 12, 1999 | Supplement 113Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 115Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 114Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 109Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 108Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 112Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 111Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 110Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 103Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 105Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 100Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 101Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1988 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 95Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 88Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 93Manufacturing · Standard review | Approved | None posted |
| Dec 6, 1985 | Supplement 94Manufacturing · 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 84Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 86Labeling | Approved | None posted |
| Sep 30, 1985 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1985 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 90Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1985 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1984 | Supplement 83Manufacturing · 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 64Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 65Labeling | 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 |
| Oct 25, 1983 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1982 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1982 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1982 | Supplement 51Labeling | Approved | None posted |
| Jun 9, 1982 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1981 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1981 | Supplement 53Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 50Labeling | Approved | None posted |
| Feb 18, 1981 | Supplement 52Labeling | Approved | None posted |
| Jan 7, 1981 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1980 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| May 2, 1980 | Supplement 39Labeling | Approved | None posted |
| May 2, 1980 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 43Labeling | Approved | None posted |
| Feb 12, 1980 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1980 | Supplement 33Labeling | Approved | None posted |
| Jan 22, 1980 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1979 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1979 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1979 | Supplement 42Manufacturing · Standard review | 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 |
| Jun 26, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1978 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Feb 13, 1978 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1978 | Supplement 20Labeling | Approved | None posted |
| Jan 23, 1978 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1977 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1977 | Supplement 13Labeling | Approved | None posted |
| May 20, 1977 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1977 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1977 | Supplement 8Labeling | Approved | None posted |
| Nov 8, 1976 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 28, 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
