Omlonti

Santen Incorporated🇺🇸 United States

FDA Page

Effective Date: Oct 9, 2023
Approval ID: 8e440b2c-fbe5-4c86-b7f3-3da00a5b2924
Products: 1 registered
Version: 11

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OMLONTI safely and effectively. See full prescribing information for OMLONTI . OMLONTI (omidenepag isopropyl ophthalmic solution) 0.002%, for topical ophthalmic use Initial U.S. Approval: 2022

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.