ANDA 211190, held by Fresenius Kabi USA. Dextrose; Sodium Chloride.
As of Nov 15, 2026, ANDA 211190 (Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Dec 20, 2019, with 0 approved supplements and 0 published complete response letters.
2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container2.5GM/100ML;450MG/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
