Prevents hypokalemia with or without metabolic alkalosis. ANDA 215725, held by Rubicon Research. Potassium Chloride.
As of Nov 15, 2026, ANDA 215725 (Potassium Chloride), held by Rubicon Research, was first approved by FDA on Jul 25, 2022, with 2 approved supplements and 0 published complete response letters.
Potassium chloride extended-release tablets are 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 is insufficient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2022 | Original application | Approved | None posted |
| Potassium Chloride10MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride20MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride15MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Aug 22, 2024 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 15, 2023 | Supplement 2Manufacturing | Approved | None posted |
| Jul 25, 2022 | 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
