← FDA DRUG APPROVALS

FDA NDA · NDA201923

ILUVIEN

fluocinolone acetonide

Sponsor: ALIMERA SCIENCES INC

APPLICATION
NDA201923
TYPE
NDA
ORIGINAL APPROVAL
2014-09-26
LATEST ACTION
2025-03-12
ROUTE
INTRAVITREAL
DOSAGE FORM
IMPLANT
MARKETING STATUS
Prescription

Products

ILUVIEN · ReferencePrescription
FLUOCINOLONE ACETONIDE 0.19MG · IMPLANT · INTRAVITREAL

Approval history

2025-03-12Labeling · Supplement 6 · standard — Letter ↗AP
2017-03-08Labeling · Supplement 2 · standard — Label ↗AP
2015-05-18Manufacturing (CMC) · Supplement 1 · priorityAP
2014-09-26Type 3 - New Dosage Form · Original · priority — 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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