MedPath

Sotalol

Generic Name
Sotalol
Brand Names
Betapace, Sorine, Sotylize
Drug Type
Small Molecule
Chemical Formula
C12H20N2O3S
CAS Number
3930-20-9
Unique Ingredient Identifier
A6D97U294I

Overview

Sotalol is a methanesulfonanilide developed in 1960. It was the first of the class III anti arrhythmic drugs. Sotalol was first approved as an oral tablet on 30 October 1992. A racemic mixture of sotalol is currently formulated as a tablet, oral solution, and intravenous injection indicated for life threatening ventricular arrhythmias and maintaining normal sinus rhythm in atrial fibrillation or flutter.

Indication

Sotalol is indicated to treat life threatening ventricular arrhytmias and maintain normal sinus rhythm in patients with atrial fibrillation or flutter. There are also oral solutions and intravenous injections indicated for patients requiring sotalol, but for whom a tablet would not be appropriate.

Associated Conditions

  • Sinus Rhythm
  • Life-threatening ventricular arrhythmias

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2022/06/14
Phase 4
UNKNOWN
2022/03/15
N/A
Completed
2022/02/18
N/A
Completed
2019/10/16
N/A
Completed
Samir Saba
2019/03/29
Phase 4
UNKNOWN
2019/02/19
Not Applicable
Completed
Maatschap Cardiologie Zwolle
2019/01/10
Phase 1
Completed
2015/12/08
Phase 3
Completed
Edgar Jaeggi
2015/01/27
Phase 4
Recruiting
2014/11/19
Not Applicable
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Carilion Materials Management
68151-2702
ORAL
80 mg in 1 1
2/22/2016
Major Pharmaceuticals
0904-7143
ORAL
80 mg in 1 1
11/24/2021
Physicians Total Care, Inc.
54868-5549
ORAL
160 mg in 1 1
4/23/2012
Apotex Corp.
60505-0159
ORAL
120 mg in 1 1
7/5/2023
PD-Rx Pharmaceuticals, Inc.
72789-138
ORAL
120 mg in 1 1
2/8/2024
Bayshore Pharmaceuticals LLC
76385-116
ORAL
160 mg in 1 1
12/6/2017
Bryant Ranch Prepack
63629-2422
ORAL
80 mg in 1 1
2/2/2022
Teva Pharmaceuticals USA, Inc.
0093-1062
ORAL
160 mg in 1 1
1/25/2023
Proficient Rx LP
71205-046
ORAL
80 mg in 1 1
11/1/2022
Proficient Rx LP
63187-426
ORAL
80 mg in 1 1
11/1/2019

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SotaHexal 80mg Tablet
SIN13311P
TABLET, FILM COATED
80mg
7/3/2007
APO-SOTALOL TABLET 160 mg
SIN09139P
TABLET
160 mg
1/13/1997

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
MYLAN-SOTALOL
Mylan Pharmaceuticals ULC
02229779
Tablet - Oral
160 MG
10/21/1996
MYLAN-SOTALOL
Mylan Pharmaceuticals ULC
02229778
Tablet - Oral
80 MG
10/21/1996
LINSOTALOL -TAB 160MG
linson pharma co.
02170841
Tablet - Oral
160 MG
12/31/1995
LINSOTALOL - TAB 80MG
linson pharma co.
02170833
Tablet - Oral
80 MG
12/31/1995
APO-SOTALOL
02167794
Tablet - Oral
160 MG
12/31/1995
SOTACOR TAB 80MG
bristol labs division of bristol-myers squibb
00897272
Tablet - Oral
80 MG
12/31/1993
SANDOZ SOTALOL
02257831
Tablet - Oral
80 MG
9/21/2004
RHOXAL-SOTALOL
rhoxalpharma inc
02234008
Tablet - Oral
80 MG
12/2/1997
NOVO-SOTALOL TAB 80MG
novopharm limited
02231181
Tablet - Oral
80 MG
5/13/1997
RIVA-SOTALOL
laboratoire riva inc.
02272164
Tablet - Oral
80 MG
6/4/2010

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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