Sotalol Hydrochloride

Treats life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm. ANDA 75563, held by Oxford Pharms. Sotalol Hydrochloride.

As of Nov 15, 2026, ANDA 75563 (Sotalol Hydrochloride), held by Oxford Pharms, was first approved by FDA on Nov 7, 2003, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 7, 2003
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (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).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 7, 2003	Original application	Approved	None posted

Products

4 strengths and forms


Sotalol Hydrochloride80MG · tablet;oral	Sotalol Hydrochloride	Rx
Sotalol Hydrochloride120MG · tablet;oral	Sotalol Hydrochloride	Rx
Sotalol Hydrochloride160MG · tablet;oral	Sotalol Hydrochloride	Rx
Sotalol Hydrochloride240MG · tablet;oral	Sotalol Hydrochloride	Rx

All 7 submissions, including labeling and manufacturing supplements


Sep 12, 2023	Supplement 24Labeling · Standard review	Approved	None posted
Feb 28, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Oct 29, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Apr 28, 2015	Supplement 7Labeling	Approved	None posted
Apr 28, 2011	Supplement 6Labeling	Approved	None posted
Mar 1, 2007	Supplement 3Labeling	Approved	None posted
Nov 7, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 75563
Drugs@FDA: Overview at FDA
Company: Oxford Pharmaceuticals

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