Treats life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm. ANDA 76214, held by Apotex. Sotalol Hydrochloride.
As of Nov 15, 2026, ANDA 76214 (Sotalol Hydrochloride), held by Apotex, was first approved by FDA on Aug 27, 2003, with 3 approved supplements and 0 published complete response letters.
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) Limitations of Use Sotalol hydrochloride has not been shown to enhance survival in patients with life threatening ventricular arrhythmias Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2003 | Original application | Approved | None posted |
| Sotalol Hydrochloride80MG · tablet;oral | Sotalol Hydrochloride | Rx |
| Sotalol Hydrochloride120MG · tablet;oral | Sotalol Hydrochloride | Rx |
| Sotalol Hydrochloride160MG · tablet;oral | Sotalol Hydrochloride | Rx |
| Sep 11, 2023 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jan 27, 2021 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jul 1, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 27, 2003 | 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
