Prevents hypokalemia with or without metabolic alkalosis. ANDA 210041, held by Amneal. Potassium Chloride.
As of Nov 15, 2026, ANDA 210041 (Potassium Chloride), held by Amneal, was first approved by FDA on Jul 19, 2018, with 2 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 |
|---|---|---|---|
| Jul 19, 2018 | Original application | Approved | None posted |
| Potassium Chloride20MEQ/15ML · solution;oral | Potassium Chloride | Rx |
| Potassium Chloride40MEQ/15ML · solution;oral | Potassium Chloride | Rx |
| Dec 19, 2022 | Supplement 6Manufacturing | Approved | None posted |
| Jul 16, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 19, 2018 | Original application | Approved | None posted |
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
