Sotalol Hydrochloride

Treats life-threatening ventricular arrhythmias. ANDA 207428, held by Regcon Holdings. Sotalol Hydrochloride.

As of Nov 15, 2026, ANDA 207428 (Sotalol Hydrochloride), held by Regcon Holdings, was first approved by FDA on Oct 21, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 21, 2016
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Sotalol/Sotalol AF is 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 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/Sotalol AF is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 21, 2016	Original application	Approved	None posted

Products

3 strengths and forms


Sotalol Hydrochloride80MG · tablet;oral	Sotalol Hydrochloride	Rx
Sotalol Hydrochloride120MG · tablet;oral	Sotalol Hydrochloride	Rx
Sotalol Hydrochloride160MG · tablet;oral	Sotalol Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 30, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Oct 21, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 207428
Drugs@FDA: Overview at FDA
Company: Regcon Holdings

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