Bupropion hydrochloride (XL)(These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL).BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral useInitial U.S. Approval: 1985)

Lannett Company Inc.🇺🇸 United States

FDA Page

Effective Date: Dec 31, 2025
Approval ID: 15c4e95a-d203-4caf-b6c7-44792355cb76
Products: 2 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL).BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral useInitial U.S. Approval: 1985

Quick Stats

Total Products2

Labelers1

Label Sections19

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.