Prevents hypokalemia with or without metabolic alkalosis. ANDA 210200, held by Epic Pharma LLC. Potassium Chloride.
As of Nov 15, 2026, ANDA 210200 (Potassium Chloride), held by Epic Pharma LLC, was first approved by FDA on Nov 23, 2018, 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 is insufficient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 23, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Chloride20MEQ · for solution;oral | Potassium Chloride | Rx |
| Apr 26, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 23, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 23, 2018 | 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
