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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 021151


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NDA 021151 describes BETAPACE AF, which is a drug marketed by Covis Pharma Bv and is included in one NDA. It is available from two suppliers. 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. Sixteen suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 021151
Tradename:BETAPACE AF
Applicant:Covis Pharma Bv
Ingredient:sotalol hydrochloride
Patents:0
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 Skyepharma Production SAS 13672-054 13672-054-00 60 mg in 1 BOTTLE (13672-054-00)
BETAPACE AF sotalol hydrochloride TABLET;ORAL 021151 NDA Skyepharma Production SAS 13672-055 13672-055-00 60 mg in 1 BOTTLE (13672-055-00)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Medtronic
Mallinckrodt
Dow
Colorcon

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