ANDA 211194, held by Fresenius Kabi USA. Dextrose; Sodium Chloride.
As of Nov 15, 2026, ANDA 211194 (Dextrose 5% And Sodium Chloride 0.3% In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Aug 26, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 5% And Sodium Chloride 0.3% In Plastic Container5GM/100ML;300MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Rx |
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
