Sotalol Hydrochloride

Treats life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm. ANDA 75429, held by Teva. Sotalol Hydrochloride.

As of Nov 15, 2026, ANDA 75429 (Sotalol Hydrochloride), held by Teva, was first approved by FDA on May 1, 2000, with 10 approved supplements and 0 published complete response letters.

First approved: May 1, 2000
Supplements approved: 10
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 11 submissions below

Date	Submission	Status	Documents
May 1, 2000	Original application	Approved	Label Letter Review Letter

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 11 submissions, including labeling and manufacturing supplements


May 15, 2024	Supplement 30Labeling · Standard review	Approved	None posted
Oct 25, 2022	Supplement 26Labeling · Standard review	Approved	None posted
Feb 4, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Oct 24, 2014	Supplement 16Manufacturing	Approved	None posted
Sep 4, 2014	Supplement 14Labeling	Approved	None posted
Jan 11, 2012	Supplement 12Labeling	Approved	None posted
Apr 28, 2011	Supplement 13Labeling	Approved	None posted
Dec 26, 2006	Supplement 11Labeling	Approved	None posted
Dec 3, 2002	Supplement 2Labeling	Approved	None posted
Oct 13, 2000	Supplement 1Labeling	Approved	None posted
May 1, 2000	Original application	Approved	Label Letter Review Letter

Identifiers

Application: ANDA 75429
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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