NDA 18268, held by B Braun. Dextrose; Potassium Chloride; Sodium Chloride.
As of Nov 13, 2026, NDA 18268 (Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.15% In Plastic Container, Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.22% In Plastic Container, Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.3% In Plastic Container), held by B Braun, was first approved by FDA on Sep 5, 1980, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.15% In Plastic Container5GM/100ML;150MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.22% In Plastic Container5GM/100ML;220MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.3% In Plastic Container5GM/100ML;300MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 0.15% In Plastic Container5GM/100ML;150MG/100ML;200MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 0.224% In Plastic Container5GM/100ML;220MG/100ML;200MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 0.3% In Plastic Container5GM/100ML;300MG/100ML;200MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 0.075%5GM/100ML;75MG/100ML;200MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.075%5GM/100ML;75MG/100ML;450MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.075% In Plastic Container5GM/100ML;75MG/100ML;330MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.15% In Plastic Container5GM/100ML;150MG/100ML;330MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.22% In Plastic Container5GM/100ML;220MG/100ML;330MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.30% In Plastic Container5GM/100ML;300MG/100ML;330MG/100ML · injectable;injection | Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Sep 11, 1990 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1986 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1986 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1986 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jun 28, 1985 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jun 27, 1985 | Supplement 16Labeling · Standard review | Approved | None posted |
| Apr 3, 1985 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1984 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 29, 1981 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 26, 1981 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 2, 1981 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1980 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 12, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1980 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 5, 1980 | 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
