Prevents hypokalemia with or without metabolic alkalosis. ANDA 209688, held by Twi Pharms. Potassium Chloride.
As of Nov 15, 2026, ANDA 209688 (Potassium Chloride), held by Twi Pharms, was first approved by FDA on Jan 12, 2018, 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 |
|---|---|---|---|
| Jan 12, 2018 | Original application | Approved | None posted |
| Potassium Chloride10MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride20MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Feb 1, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 12, 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
