Prevents hypokalemia with or without metabolic alkalosis. ANDA 213467, held by Granules. Potassium Chloride.
As of Nov 15, 2026, ANDA 213467 (Potassium Chloride), held by Granules, was first approved by FDA on Jan 27, 2022, with 0 approved supplements and 0 published complete response letters.
Potassium Chloride for 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 is insufficient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Chloride20MEQ · for 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
