NDA 20000, held by B Braun. Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride.
As of Nov 13, 2026, NDA 20000 (Dextrose 5% In Ringer'S In Plastic Container), held by B Braun, was first approved by FDA on Apr 17, 1992, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 17, 1992 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 5% In Ringer'S In Plastic Container33MG/100ML;5GM/100ML;30MG/100ML;860MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 1, 2003 | Supplement 11Labeling | Approved | None posted |
| Jun 18, 2003 | Supplement 10Labeling | Approved | None posted |
| Jul 1, 2002 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 15, 2002 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 7, 2000 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1993 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 10, 1993 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 17, 1992 | 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
