Difluprednate Ophthalmic

Sandoz Inc🇺🇸 United States

FDA Page

Effective Date: Aug 18, 2026
Approval ID: 0f60b857-7898-4a9e-935c-a9ddf0eb9194
Products: 1 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use DIFLUPREDNATE OPHTHALMIC EMULSION safely and effectively. See full prescribing information for DIFLUPREDNATE OPHTHALMIC EMULSION.DIFLUPREDNATE ophthalmic emulsion 0.05%, for topical ophthalmic use Initial U.S. Approval: 2008

Quick Stats

Total Products1

Labelers2

Label Sections27

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.