FDA NDA · NDA022212

DIFLUPREDNATE OPHTHALMIC

Sponsor: SANDOZ

APPLICATION

NDA022212

TYPE

NDA

ORIGINAL APPROVAL

2008-06-23

LATEST ACTION

2025-10-27

ROUTE

OPHTHALMIC

DOSAGE FORM

EMULSION

MARKETING STATUS

Prescription

Products

DUREZOL · ReferencePrescription

DIFLUPREDNATE 0.05% · EMULSION · OPHTHALMIC

2025-10-27Labeling · Supplement 25 · standard — Label ↗AP

2025-07-15Labeling · Supplement 18 · standard — Letter ↗AP

2016-07-29Labeling · Supplement 16 · standard — Label ↗AP

2016-04-11Manufacturing (CMC) · Supplement 15 · priority — Review ↗AP

2013-05-15Labeling · Supplement 12 · standard — Letter ↗AP

2013-03-22Efficacy · Supplement 11 · priority — Label ↗AP

2012-11-27Manufacturing (CMC) · Supplement 10 · priority — Label ↗AP

2012-06-13Efficacy · Supplement 3 · standard — Letter ↗AP

2009-03-20Labeling · Supplement 1 · standard — Letter ↗AP

2008-06-23Type 1 - New Molecular Entity · Original · priority — Summary Review ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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