Durezol

Treats inflammation and pain associated with ocular surgery. NDA 22212, held by Sandoz. Difluprednate.

As of Nov 13, 2026, NDA 22212 (Durezol), held by Sandoz, was first approved by FDA on Jun 23, 2008, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2008
Review: Priority
Supplements approved: 10
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; all 11 submissions below


Mar 22, 2013	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 1 Pediatric Written Request
Jun 13, 2012	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 23, 2008	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Durezol0.05% · emulsion;ophthalmic	Difluprednate	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Aug 12, 2026	Supplement 26Labeling · Standard review	Approved	Label Letter
Oct 27, 2025	Supplement 25Labeling · Standard review	Approved	Label Letter
Jul 15, 2025	Supplement 18Labeling · Standard review	Approved	Label Letter
Jul 29, 2016	Supplement 16Labeling · Standard review	Approved	Label Letter
Apr 11, 2016	Supplement 15Manufacturing · Priority review	Approved	Review
May 15, 2013	Supplement 12Labeling · Standard review	Approved	Label Letter
Mar 22, 2013	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 1 Pediatric Written Request
Nov 27, 2012	Supplement 10Manufacturing · Priority review	Approved	Label Letter
Jun 13, 2012	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 20, 2009	Supplement 1Labeling · Standard review	Approved	Letter
Jun 23, 2008	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22212
Drugs@FDA: Overview at FDA
Company: Sandoz

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