Prevents hypokalemia. ANDA 202128, held by Amneal Pharms. Potassium Chloride.
As of Nov 15, 2026, ANDA 202128 (Potassium Chloride), held by Amneal Pharms, was first approved by FDA on Feb 22, 2013, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE 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 |
|---|---|---|---|
| Feb 22, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| 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
