ANDA 212589, held by Adaptis. Quinidine Gluconate.
As of Nov 15, 2026, ANDA 212589 (Quinidine Gluconate), held by Adaptis, was first approved by FDA on Sep 17, 2021, with 1 approved supplement and 0 published complete response letters.
INDICATIONS & USAGE Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION ), then quinidine gluconate should be discontinued.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Quinidine Gluconate324MG · tablet, extended release;oral | Quinidine Gluconate | Rx |
| Jan 27, 2023 | Supplement 2Manufacturing | Approved | None posted |
| Sep 17, 2021 | Original application | Approved |
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
