← FDA DRUG APPROVALS

FDA NDA · NDA022315

OZURDEX

dexamethasone

Sponsor: ABBVIE

APPLICATION
NDA022315
TYPE
NDA
ORIGINAL APPROVAL
2009-06-17
LATEST ACTION
2026-03-11
ROUTE
INTRAVITREAL
DOSAGE FORM
IMPLANT
MARKETING STATUS
Prescription

Products

OZURDEX · ReferencePrescription
DEXAMETHASONE 0.7MG · IMPLANT · INTRAVITREAL

Approval history

2026-03-11Labeling · Supplement 19 · standard — Label ↗AP
2022-12-19Labeling · Supplement 16 · standard — Label ↗AP
2020-10-21Labeling · Supplement 13 · standard — Letter ↗AP
2018-05-15Labeling · Supplement 12 · standard — Letter ↗AP
2016-02-05Manufacturing (CMC) · Supplement 11 · priorityAP
2014-09-26Labeling · Supplement 10 · standard — Letter ↗AP
2014-06-28Efficacy · Supplement 9 · standard — Review ↗AP
2014-02-07Labeling · Supplement 8 · standard — Letter ↗AP
2012-09-07Labeling · Supplement 7 · standard — Letter ↗AP
2012-02-24Labeling · Supplement 5 · standard — Label ↗AP
2010-09-24Efficacy · Supplement 3 · standard — Label ↗AP
2010-08-31Labeling · Supplement 2 · unknown — Letter ↗AP
2009-06-17Type 3 - New Dosage Form · Original · priority — Review ↗AP
—Labeling · Supplement 20 · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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