Treats hypokalemia with or without metabolic alkalosis, in digitalis intoxication. ANDA 76368, held by Adare Pharms Inc. Potassium Chloride.
As of Nov 15, 2026, ANDA 76368 (Potassium Chloride), held by Adare Pharms Inc, was first approved by FDA on Aug 18, 2004, with 1 approved supplement 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 |
|---|---|---|---|
| Aug 18, 2004 | Original application | Approved | None posted |
| Potassium Chloride20MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride10MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Jun 29, 2009 | Supplement 6Labeling | Approved | None posted |
| Aug 18, 2004 | 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
