NDA 17634, held by Baxter Hlthcare. Dextrose; Potassium Chloride.
As of Nov 13, 2026, NDA 17634 (Dextrose 5% And Potassium Chloride 0.15% In Plastic Container, Dextrose 5% And Potassium Chloride 0.3% In Plastic Container, Dextrose 5% And Potassium Chloride 0.224% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Feb 1, 1979, with 55 approved supplements and 0 published complete response letters.
Potassium Chloride in Dextrose Injection is indicated as a source of water, electrolytes and calories.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Dextrose 5% And Potassium Chloride 0.15% In Plastic Container5GM/100ML;150MG/100ML · injectable;injection | Dextrose; Potassium Chloride | RxReference drug |
| Dextrose 5% And Potassium Chloride 0.3% In Plastic Container5GM/100ML;300MG/100ML · injectable;injection | Dextrose; Potassium Chloride | RxReference drug |
| Dextrose 5% And Potassium Chloride 0.224% In Plastic Container5GM/100ML;224MG/100ML · injectable;injection | Dextrose; Potassium Chloride | RxReference drug |
| Dextrose 5% And Potassium Chloride 0.075% In Plastic Container5GM/100ML;75MG/100ML · injectable;injection | Dextrose; Potassium Chloride | RxReference drug |
| Jul 15, 2019 | Supplement 76Labeling · Standard review | Approved | |
| May 26, 2017 | Supplement 71Labeling · Standard review | Approved | |
| May 26, 2017 | Supplement 73Labeling · Standard review | Approved | |
| Dec 22, 2014 | Supplement 69Labeling · Standard review | Approved | |
| Sep 25, 2014 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Aug 26, 2005 | Supplement 65Manufacturing · Standard review | Approved | |
| May 23, 2005 | Supplement 64Labeling · Standard review | Approved | |
| Jan 3, 2003 | Supplement 59Labeling · Standard review | Approved | |
| Aug 14, 2001 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Nov 24, 1999 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Feb 14, 1992 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1991 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1991 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jan 12, 1989 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1987 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| May 28, 1987 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1986 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1985 | Supplement 41Labeling | Approved | None posted |
| Jun 13, 1985 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1985 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Oct 23, 1984 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1984 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1983 | Supplement 27Labeling | Approved | None posted |
| Mar 1, 1983 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1983 | Supplement 14Labeling | Approved | None posted |
| Jun 3, 1982 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| May 25, 1982 | Supplement 30Labeling | Approved | None posted |
| Apr 16, 1982 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Apr 12, 1982 | Supplement 29Labeling | Approved | None posted |
| Dec 21, 1981 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1981 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1981 | Supplement 21Labeling | Approved | None posted |
| Jun 29, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| May 29, 1981 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1981 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1981 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1980 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 22, 1980 | Supplement 12Labeling | Approved | None posted |
| Jun 28, 1980 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 30, 1980 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 28, 1980 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 28, 1980 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1979 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1979 | 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
