Treats hypokalemia with or without metabolic alkalosis, in digitalis intoxication. ANDA 210395, held by Zydus Pharms. Potassium Chloride.
As of Nov 15, 2026, ANDA 210395 (Potassium Chloride), held by Zydus Pharms, was first approved by FDA on Sep 17, 2020, with 0 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 |
|---|---|---|---|
| Sep 17, 2020 | Original application | Approved | None posted |
| Potassium Chloride10MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride20MEQ · tablet, 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
