Hydromorphone Hydrochloride

Trigen Laboratories, LLC🇺🇸 United States

FDA Page

Effective Date: Sep 22, 2025
Approval ID: 8bb81796-6990-40e9-bee4-1f292f91ae99
Products: 5 registered
Version: 23

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. HYDROMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 1984

Quick Stats

Total Products5

Labelers2

Label Sections44

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.