Prevents hypokalemia with or without metabolic alkalosis. NDA 208019, held by Genus. Potassium Chloride.
As of Nov 13, 2026, NDA 208019 (Potassium Chloride, Pokonza), held by Genus, was first approved by FDA on Aug 19, 2015, with 3 approved supplements and 0 published complete response letters.
POKONZA (Potasium Chloride for Oral Solution, USP) 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 |
|---|---|---|---|
| Aug 19, 2015 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Chloride20MEQ · for solution;oral | Potassium Chloride | RxReference drug |
| Pokonza10MEQ · for solution;oral | Potassium Chloride | RxReference drug |
| Potassium Chloride40MEQ · for solution;oral | Potassium Chloride | DiscontinuedReference drug |
| Pokonza15MEQ · for solution;oral | Potassium Chloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 12, 2025 | Supplement 8Manufacturing | Approved | |
| Mar 5, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Jul 10, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Aug 19, 2015 | 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
