Treats life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm. ANDA 77616, held by Aurobindo Pharma USA. Sotalol Hydrochloride.
As of Nov 15, 2026, ANDA 77616 (Sotalol Hydrochloride), held by Aurobindo Pharma USA, was first approved by FDA on Feb 7, 2007, with 3 approved supplements and 0 published complete response letters.
Sotalol hydrochloride tablets (AF) 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 tablets (AF) 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 1.1 Life-Threatening Ventricular Arrhythmias Sotalol hydrochloride tablets (AF) are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2007 | 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 |
| Apr 30, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 30, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Aug 25, 2015 | Supplement 4Labeling | Approved | None posted |
| Feb 7, 2007 | 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
