Prevents hypokalemia with or without metabolic alkalosis. ANDA 204662, held by Pharmobedient. Potassium Chloride.
As of Nov 15, 2026, ANDA 204662 (Potassium Chloride), held by Pharmobedient, was first approved by FDA on Aug 21, 2014, with 1 approved supplement and 0 published complete response letters.
Potassium chloride extended-release tablets are 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 21, 2014 | Original application | Approved | None posted |
| Potassium Chloride8MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride10MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Apr 15, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 21, 2014 | 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
