TAPENTADOL

Hikma Pharmaceuticals USA Inc.🇺🇸 United States

FDA Page

Effective Date: Feb 26, 2026
Approval ID: 38de863e-56ff-4c43-9ab8-9b3e1ba82858
Products: 5 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use Tapentadol extended-release tablets safely and effectively. See full prescribing information for tapentadol extended-release tablet Tapentadol extended-release tablet for oral use C-II Initial U.S. Approval: 2008

Quick Stats

Total Products5

Labelers1

Label Sections20

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.