Prevents hypokalemia with or without metabolic alkalosis. ANDA 218979, held by Twi Pharms. Potassium Chloride.
As of Nov 15, 2026, ANDA 218979 (Klor-Con), held by Twi Pharms, was first approved by FDA on Oct 28, 2024, 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 |
|---|---|---|---|
| Oct 28, 2024 | Original application | Approved | None posted |
| Klor-Con8MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Klor-Con10MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Oct 27, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 28, 2024 | 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
