Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
Argus Health
Cantor Fitzgerald

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021151

« Back to Dashboard

NDA 021151 describes BETAPACE AF, which is a drug marketed by Covis Pharma Bv and is included in one NDA. It is available from one supplier. Additional details are available on the BETAPACE AF profile page.

The generic ingredient in BETAPACE AF is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 021151
Applicant:Covis Pharma Bv
Ingredient:sotalol hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021151
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration
Medical Subject Heading (MeSH) Categories for 021151
Suppliers and Packaging for NDA: 021151
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETAPACE AF sotalol hydrochloride TABLET;ORAL 021151 NDA Covis Pharma 70515-115 N 70515-115-06
BETAPACE AF sotalol hydrochloride TABLET;ORAL 021151 NDA Covis Pharma 70515-116 N 70515-116-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Feb 22, 2000TE:AB2RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:Feb 22, 2000TE:AB2RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Feb 22, 2000TE:AB2RLD:Yes

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Express Scripts
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.