BETAPACE

Legacy Pharma USA, Inc.🇺🇸 United States

FDA Page

Effective Date: Jun 15, 2023
Approval ID: a6a7702f-36c9-45db-b640-453dc324baee
Products: 6 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BETAPACE/BETAPACE AF safely and effectively. See full prescribing information for BETAPACE/BETAPACE AF. BETAPACE (sotalol hydrochloride) tablets, for oral useBETAPACE AF (sotalol hydrochloride) tablets, for oral useInitial U.S. Approval: 1992

Quick Stats

Total Products6

Labelers2

Label Sections22

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.