Prevents hypokalemia with or without metabolic alkalosis. ANDA 211648, held by Sciegen Pharms. Potassium Chloride.
As of Nov 15, 2026, ANDA 211648 (Potassium Chloride), held by Sciegen Pharms, was first approved by FDA on May 21, 2021, with 2 approved supplements and 0 published complete response letters.
Potassium chloride oral solution 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 |
|---|---|---|---|
| May 21, 2021 | Original application | Approved | None posted |
| Potassium Chloride20MEQ/15ML · solution;oral | Potassium Chloride | Rx |
| Potassium Chloride40MEQ/15ML · solution;oral | Potassium Chloride | Rx |
| Jan 5, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 5, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 21, 2021 | 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
