NDA 18008, held by Baxter Hlthcare. Dextrose; Potassium Chloride; Sodium Chloride.
As of Nov 13, 2026, NDA 18008 (Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 20meq (K) In Plastic Container, Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 5meq In Plastic Container, Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 15meq In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Feb 2, 1979, with 54 approved supplements and 0 published complete response letters.
Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 20meq (K) In Plastic Container5GM/100ML;300MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 5meq In Plastic Container5GM/100ML;75MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 15meq In Plastic Container5GM/100ML;224MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Potassium Chloride 5meq In Dextrose 5% And Sodium Chloride 0.45% In Plastic Container5GM/100ML;150MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Rx |
| Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.45% In Plastic Container5GM/100ML;75MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Rx |
| Potassium Chloride 10meq In Dextrose 5% And Sodium Chloride 0.45% In Plastic Container5GM/100ML;150MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Rx |
| Potassium Chloride 20meq In Dextrose 5% And Sodium Chloride 0.45% In Plastic Container5GM/100ML;150MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Rx |
| Potassium Chloride 30meq In Dextrose 5% And Sodium Chloride 0.45% In Plastic Container5GM/100ML;224MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Rx |
| Potassium Chloride 40meq In Dextrose 5% And Sodium Chloride 0.45% In Plastic Container5GM/100ML;300MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Rx |
| Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 20meq (K) In Plastic Container5GM/100ML;300MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Rx |
| Feb 21, 2019 | Supplement 73Labeling · Standard review | Approved | |
| Sep 26, 2014 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Sep 10, 2013 | Supplement 70Labeling · Standard review | Approved | |
| Apr 20, 2007 | Supplement 66Labeling · Standard review | Approved | |
| Aug 26, 2005 | Supplement 65Manufacturing · Standard review | Approved | |
| Jun 2, 2004 | Supplement 63Labeling · Standard review | Approved | |
| Apr 14, 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 |
| Apr 22, 1993 | Supplement 54Labeling · Standard review | Approved | None posted |
| Dec 11, 1991 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1991 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1991 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jul 26, 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 44Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1985 | Supplement 42Labeling | Approved | None posted |
| Jun 13, 1985 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1985 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Oct 23, 1984 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1984 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1983 | Supplement 29Labeling | Approved | None posted |
| Jun 3, 1982 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| May 25, 1982 | Supplement 32Labeling | Approved | None posted |
| Apr 28, 1982 | Supplement 31Labeling | Approved | None posted |
| Apr 16, 1982 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1981 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1981 | Supplement 23Labeling | Approved | None posted |
| Jun 29, 1981 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| May 29, 1981 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1981 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1980 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1980 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1980 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1980 | Supplement 3Manufacturing · 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 8Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1980 | Supplement 12Labeling | Approved | None posted |
| Aug 2, 1979 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1979 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 2, 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
