NDA 19631, held by B Braun. Dextrose; Sodium Chloride.
As of Nov 14, 2026, NDA 19631 (Dextrose 2.5% And Sodium Chloride 0.11% In Plastic Container, Dextrose 2.5% And Sodium Chloride 0.2% In Plastic Container, Dextrose 2.5% And Sodium Chloride 0.33% In Plastic Container), held by B Braun, was first approved by FDA on Feb 24, 1988, with 24 approved supplements and 0 published complete response letters.
Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes, and calories in adults and pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 1988 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Dextrose 2.5% And Sodium Chloride 0.11% In Plastic Container2.5GM/100ML;110MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 2.5% And Sodium Chloride 0.2% In Plastic Container2.5GM/100ML;200MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 2.5% And Sodium Chloride 0.33% In Plastic Container2.5GM/100ML;330MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container2.5GM/100ML;450MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 2.5% And Sodium Chloride 0.9% In Plastic Container2.5GM/100ML;900MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 5% And Sodium Chloride 0.11% In Plastic Container5GM/100ML;110MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 5% And Sodium Chloride 0.2% In Plastic Container5GM/100ML;200MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 5% And Sodium Chloride 0.33% In Plastic Container5GM/100ML;330MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 5% And Sodium Chloride 0.45% In Plastic Container5GM/100ML;450MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 5% And Sodium Chloride 0.9% In Plastic Container5GM/100ML;900MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 10% And Sodium Chloride 0.11% In Plastic Container10GM/100ML;110MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 10% And Sodium Chloride 0.2% In Plastic Container10GM/100ML;200MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 10% And Sodium Chloride 0.33% In Plastic Container10GM/100ML;330MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 10% And Sodium Chloride 0.45% In Plastic Container10GM/100ML;450MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 10% And Sodium Chloride 0.9% In Plastic Container10GM/100ML;900MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Dextrose 3.3% And Sodium Chloride 0.3% In Plastic Container3.3GM/100ML;300MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
| Sep 29, 2026 | Supplement 53Labeling · Standard review | Approved | |
| Aug 22, 2014 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jan 24, 2014 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Sep 27, 2004 | Supplement 23Labeling · Standard review | Approved | |
| Jul 23, 2002 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 8, 2002 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Mar 12, 2001 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 11, 2000 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 25, 1998 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 17, 1995 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Dec 19, 1994 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1993 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Dec 29, 1992 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1991 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 18, 1990 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 13, 1990 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1990 | Supplement 9Labeling | Approved | None posted |
| Jan 19, 1990 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 21, 1989 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 5, 1989 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1988 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 25, 1988 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1988 | Supplement 1Labeling | Approved | None posted |
| Feb 24, 1988 | 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
