Treats life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm. ANDA 75500, held by Aiping Pharm Inc. Sotalol Hydrochloride.
As of Nov 15, 2026, ANDA 75500 (Sorine), held by Aiping Pharm Inc, was first approved by FDA on Apr 27, 2001, with 5 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Sotalol hydrochloride 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 tablets have 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 are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2001 | Original application | Approved |
| Sorine80MG · tablet;oral | Sotalol Hydrochloride | Rx |
| Sorine160MG · tablet;oral | Sotalol Hydrochloride | Rx |
| Sorine240MG · tablet;oral | Sotalol Hydrochloride | Rx |
| Sorine120MG · tablet;oral | Sotalol Hydrochloride | Rx |
| Feb 4, 2021 | Supplement 17Labeling · Standard review | Approved | None posted |
| Mar 2, 2015 | Supplement 14Labeling | Approved | None posted |
| Mar 2, 2015 | Supplement 15Labeling | Approved | None posted |
| May 13, 2003 | Supplement 2Labeling | Approved | None posted |
| Dec 19, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Apr 27, 2001 | 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
