Prevents hypokalemia with or without metabolic alkalosis. ANDA 209786, held by Novel Labs Inc. Potassium Chloride.
As of Nov 15, 2026, ANDA 209786 (Potassium Chloride), held by Novel Labs Inc, was first approved by FDA on Aug 29, 2018, with 2 approved supplements and 0 published complete response letters.
Potassium chloride is 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 are insufficient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2018 | Original application | Approved | None posted |
| Potassium Chloride20MEQ/15ML · solution;oral | Potassium Chloride | Rx |
| Potassium Chloride40MEQ/15ML · solution;oral | Potassium Chloride | Rx |
| Jan 19, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 30, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 29, 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
