Prevents hypokalemia with or without metabolic alkalosis. ANDA 210902, held by Amneal. Potassium Chloride.
As of Nov 15, 2026, ANDA 210902 (Potassium Chloride), held by Amneal, was first approved by FDA on May 23, 2019, with 2 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 |
|---|---|---|---|
| May 23, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Chloride20MEQ · for solution;oral | Potassium Chloride | Rx |
| Jun 19, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 23, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 23, 2019 | 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
