Prevents hypokalemia with or without metabolic alkalosis. ANDA 210766, held by Pharm Assoc. Potassium Chloride.
As of Nov 15, 2026, ANDA 210766 (Potassium Chloride), held by Pharm Assoc, was first approved by FDA on Mar 29, 2019, with 2 approved supplements and 0 published complete response letters.
Potassium Chloride 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 |
|---|---|---|---|
| Mar 29, 2019 | Original application | Approved | None posted |
| Potassium Chloride20MEQ/15ML · solution;oral | Potassium Chloride | Rx |
| Potassium Chloride40MEQ/15ML · solution;oral | Potassium Chloride | Rx |
| Nov 2, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 8, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 29, 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
