Treats hypokalemia with or without metabolic alkalosis, in digitalis intoxication. ANDA 203562, held by Glenmark Pharms Ltd. Potassium Chloride.
As of Nov 15, 2026, ANDA 203562 (Potassium Chloride), held by Glenmark Pharms Ltd, was first approved by FDA on Jul 26, 2016, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2016 | Original application | Approved | None posted |
| Potassium Chloride10MEQ · tablet, extended release;oral | Potassium Chloride | Discontinued |
| Potassium Chloride20MEQ · tablet, extended release;oral | Potassium Chloride | Discontinued |
| Feb 26, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 26, 2021 | Supplement 3Manufacturing | Approved | None posted |
| Jul 26, 2016 | 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
