Prevents hypokalemia with or without metabolic alkalosis. ANDA 216536, held by Aurobindo Pharma. Potassium Chloride.
As of Nov 15, 2026, ANDA 216536 (Potassium Chloride), held by Aurobindo Pharma, was first approved by FDA on Nov 20, 2025, with 0 approved supplements and 0 published complete response letters.
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2025 | Original application | Approved | None posted |
| Potassium Chloride20MEQ/15ML · solution;oral | Potassium Chloride | Rx |
| Potassium Chloride40MEQ/15ML · solution;oral | Potassium 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
