ANDA 212070, held by Fresenius Kabi USA. Sodium Chloride.
As of Nov 15, 2026, ANDA 212070 (Sodium Chloride 14.6%, Sodium Chloride 23.4%), held by Fresenius Kabi USA, was first approved by FDA on Apr 28, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE 23.4% Sodium Chloride Injection, USP is indicated for use as an electrolyte replenisher in parenteral fluid therapy. It serves as an additive for total parenteral nutrition (TPN) and as an additive for carbohydrate containing I.V. fluids.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2021 | Original application | Approved |
| Sodium Chloride 14.6%50MEQ/20ML (2.5MEQ/ML) · solution;intravenous | Sodium Chloride | Rx |
| Sodium Chloride 14.6%100MEQ/40ML (2.5MEQ/ML) · solution;intravenous | Sodium Chloride | Rx |
| Sodium Chloride 23.4%400MEQ/100ML (4MEQ/ML) · solution;intravenous | 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
