Treats hypokalemia with or without metabolic alkalosis, in digitalis intoxication. ANDA 206347, held by Novel Labs Inc. Potassium Chloride.
As of Nov 15, 2026, ANDA 206347 (Potassium Chloride), held by Novel Labs Inc, was first approved by FDA on Jan 21, 2016, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-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. 1. 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 |
|---|---|---|---|
| Jan 21, 2016 | 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
