Betapace

Treats life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm. NDA 19865, held by Legacy. Sotalol Hydrochloride.

As of Nov 13, 2026, NDA 19865 (Betapace), held by Legacy, was first approved by FDA on Oct 30, 1992, with 17 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1992
Review: Priority
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Betapace/Betapace 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 Betapace 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 Betapace/Betapace 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 18 submissions below

Date	Submission	Status	Documents
Oct 1, 2001	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Oct 30, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

5 strengths and forms

Product	Active ingredient	Marketing
Betapace80MG · tablet;oral	Sotalol Hydrochloride	RxReference drug
Betapace160MG · tablet;oral	Sotalol Hydrochloride	RxReference drug
Betapace240MG · tablet;oral	Sotalol Hydrochloride	RxReference drug
Betapace320MG · tablet;oral	Sotalol Hydrochloride	Discontinued
Betapace120MG · tablet;oral	Sotalol Hydrochloride	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 15, 2023	Supplement 26Labeling · Standard review	Approved	Letter Label
Jun 3, 2021	Supplement 22Labeling · Standard review	Approved	Label Letter
May 10, 2016	Supplement 21Labeling · Standard review	Approved	Letter Label
Aug 17, 2011	Supplement 20Labeling	Approved	Label Letter
Feb 3, 2011	Supplement 19Labeling	Approved	Letter Label
Oct 1, 2001	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jul 26, 2001	Supplement 14Manufacturing · Priority review	Approved	None posted
Nov 22, 2000	Supplement 12Manufacturing · Priority review	Approved	None posted
Jul 7, 2000	Supplement 11Labeling · Standard review	Approved	None posted
Aug 23, 1999	Supplement 8Labeling · Standard review	Approved	None posted
Apr 9, 1999	Supplement 9Manufacturing · Priority review	Approved	None posted
Dec 4, 1995	Supplement 6Manufacturing · Priority review	Approved	None posted
Jul 26, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Sep 6, 1994	Supplement 3Manufacturing · Priority review	Approved	None posted
Apr 20, 1994	Supplement 2Manufacturing · Priority review	Approved	None posted
Apr 20, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Apr 13, 1993	Supplement 1Manufacturing · Priority review	Approved	None posted
Oct 30, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19865
Drugs@FDA: Overview at FDA
Company: LEGACY

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