Prevents hypokalemia. ANDA 203002, held by Lupin. Potassium Chloride.
As of Nov 15, 2026, ANDA 203002 (Potassium Chloride), held by Lupin, was first approved by FDA on Dec 18, 2015, with 1 approved supplement 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 |
|---|---|---|---|
| Dec 18, 2015 | Original application | Approved | None posted |
| Potassium Chloride8MEQ · capsule, extended release;oral | Potassium Chloride | Discontinued |
| Potassium Chloride10MEQ · capsule, extended release;oral | Potassium Chloride | Discontinued |
| May 5, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 18, 2015 | 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
