Sotalol Hydrochloride

Treats life-threatening ventricular arrhythmias. ANDA 77070, held by Epic Pharma LLC. Sotalol Hydrochloride.

As of Nov 15, 2026, ANDA 77070 (Sotalol Hydrochloride), held by Epic Pharma LLC, was first approved by FDA on Nov 4, 2005, with 0 approved supplements and 0 published complete response letters.

First approved: Nov 4, 2005
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sotalol hydrochloride tablets (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 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).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Nov 4, 2005	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

Identifiers

Application: ANDA 77070
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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