Prevents hypokalemia with or without metabolic alkalosis. ANDA 212987, held by Macleods Pharms. Potassium Chloride.
As of Nov 15, 2026, ANDA 212987 (Potassium Chloride), held by Macleods Pharms, was first approved by FDA on Sep 6, 2024, with 0 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 |
|---|---|---|---|
| Sep 6, 2024 | Original application | Approved | None posted |
| Potassium Chloride8MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride10MEQ · tablet, extended release;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
