Prevents hypokalemia with or without metabolic alkalosis. ANDA 210241, held by Novel Labs Inc. Potassium Chloride.
As of Nov 15, 2026, ANDA 210241 (Potassium Chloride), held by Novel Labs Inc, was first approved by FDA on Nov 21, 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 is insufficient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Chloride20MEQ · for solution;oral | Potassium Chloride | Rx |
| Jun 19, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 19, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 21, 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
