Prevents hypokalemia. ANDA 208445, held by Zydus Pharms. Potassium Chloride.
As of Nov 15, 2026, ANDA 208445 (Potassium Chloride), held by Zydus Pharms, was first approved by FDA on Mar 11, 2019, with 0 approved supplements and 0 published complete response letters.
Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children 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 |
|---|---|---|---|
| Mar 11, 2019 | Original application | Approved | None posted |
| Potassium Chloride8MEQ · capsule, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride10MEQ · capsule, extended release;oral | Potassium Chloride | Rx |
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
