Treats sodium, chloride and water deficiencies. ANDA 212248, held by Fresenius Kabi USA. Sodium Chloride.
As of Nov 15, 2026, ANDA 212248 (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: Sodium Chloride Injection, USP, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from Sodium Chloride Injection, USP, 23.4% and diluted for use. Sodium Chloride Injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Chloride 23.4%234MG/ML · injectable;injection | 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
