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FDA NDA · NDA208742

DEXTENZA

dexamethasone

Sponsor: OCULAR THERAPEUTIX

APPLICATION
NDA208742
TYPE
NDA
ORIGINAL APPROVAL
2018-11-30
LATEST ACTION
2025-04-07
ROUTE
INTRACANALICULAR, OPHTHALMIC
DOSAGE FORM
INSERT
MARKETING STATUS
Prescription

Products

DEXTENZA · ReferencePrescription
DEXAMETHASONE 0.4MG · INSERT · OPHTHALMIC

Approval history

2025-04-07Efficacy · Supplement 13 · standard — Label ↗AP
2021-10-07Efficacy · Supplement 7 · standard — Label ↗AP
2020-03-02Labeling · Supplement 5 · standard — Letter ↗AP
2019-06-20Efficacy · Supplement 1 · standard — Label ↗AP
2018-11-30Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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