AKTEN

Thea Pharma Inc.🇺🇸 United States

FDA Page

Effective Date: Apr 23, 2026
Approval ID: 70ff9fb7-d323-4fe6-b1b1-6033e05f0749
Products: 1 registered
Version: 9

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use AKTEN safely and effectively. See full prescribing information for Akten . AKTEN (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use. Initial U.S. Approval: 1972

Quick Stats

Total Products1

Labelers2

Label Sections16

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.