Aplenzin

Bausch Health US, LLC🇺🇸 United States

FDA Page

Effective Date: Mar 2, 2022
Approval ID: 6494d2d9-0ce4-4126-b1c7-49684395942b
Products: 3 registered
Version: 18

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use APLENZIN safely and effectively. See full prescribing information for APLENZIN. APLENZIN (bupropion hydrobromide) extended-release tablets, for oral useInitial U.S. Approval: 1985

Quick Stats

Total Products3

Labelers2

Label Sections21

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.