Difluprednate

Treats inflammation and pain associated with ocular surgery. ANDA 212566, held by Mylan Labs Ltd. Difluprednate.

As of Nov 15, 2026, ANDA 212566 (Difluprednate), held by Mylan Labs Ltd, was first approved by FDA on Mar 20, 2025, with 0 approved supplements and 0 published complete response letters.

First approved: Mar 20, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Difluprednate ophthalmic emulsion is a corticosteroid indicated for:

The treatment of inflammation and pain associated with ocular surgery.
The treatment of endogenous anterior uveitis. 1.1 Ocular Surgery Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is indicated for the treatment of endogenous anterior uveitis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Mar 20, 2025	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Difluprednate0.05% · emulsion;ophthalmic	Difluprednate	Rx

Identifiers

Application: ANDA 212566
Drugs@FDA: Overview at FDA
Company: Mylan Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters