Prevents hypokalemia with or without metabolic alkalosis. NDA 206814, held by Genus Lifesciences. Potassium Chloride.
As of Nov 14, 2026, NDA 206814 (Potassium Chloride, Pokonza), held by Genus Lifesciences, was first approved by FDA on Dec 22, 2014, with 5 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 |
|---|---|---|---|
| Dec 22, 2014 | Original applicationTYPE 7 · Standard review | Approved |
| Potassium Chloride20MEQ/15ML · solution;oral | Potassium Chloride | RxReference drug |
| Potassium Chloride40MEQ/15ML · solution;oral | Potassium Chloride | RxReference drug |
| Pokonza10MEQ/15ML · solution;oral | Potassium Chloride | RxReference drug |
| Jun 12, 2026 | Supplement 13Manufacturing | Approved | |
| Mar 5, 2020 | Supplement 9Labeling · Standard review | Approved | |
| May 1, 2019 | Supplement 8Manufacturing · Standard review | Approved | |
| Feb 4, 2019 | Supplement 7Labeling · Standard review | Approved | |
| Jul 14, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 22, 2014 | Original applicationTYPE 7 · Standard review | Approved |
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
