Prolensa

Bausch & Lomb Incorporated🇺🇸 United States

FDA Page

Effective Date: May 5, 2026
Approval ID: 4e072537-f73c-4a96-a65f-e2805ce112d8
Products: 1 registered
Version: 19

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PROLENSA safely and effectively. See full prescribing information for PROLENSA. PROLENSA (bromfenac ophthalmic solution) 0.07%, for topical ophthalmic use Initial U.S. Approval: 1997

Quick Stats

Total Products1

Labelers2

Label Sections22

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.