Bepotastine Besilate(These highlights do not include all the information needed to use BEPOTASTINE BESILATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BEPOTASTINE BESILATE OPHTHALMIC SOLUTION.BEPOTASTINE BESILATE OPHTHALMIC SOLUTION, 1.5%, for topical ophthalmic useInitial U.S. Approval: 2009)

Bausch & Lomb Incorporated🇺🇸 United States

FDA Page

Effective Date: Dec 31, 2020
Approval ID: 995f4fe0-d861-4137-8090-a8ffc71c46f4
Products: 1 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BEPOTASTINE BESILATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BEPOTASTINE BESILATE OPHTHALMIC SOLUTION.BEPOTASTINE BESILATE OPHTHALMIC SOLUTION, 1.5%, for topical ophthalmic useInitial U.S. Approval: 2009

Quick Stats

Total Products1

Labelers2

Label Sections14

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.