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FDA NDA · NDA208912

DEXYCU KIT

Sponsor: EYEPOINT PHARMS

APPLICATION
NDA208912
TYPE
NDA
ORIGINAL APPROVAL
2018-02-09
LATEST ACTION
2020-06-04
ROUTE
INTRAOCULAR
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

DEXYCU KIT · ReferencePrescription
DEXAMETHASONE 9% · SUSPENSION · INTRAOCULAR

Approval history

2020-06-04Labeling · Supplement 2 · standardLabelAP
2018-02-09Type 5 - New Formulation or New Manufacturer · Original · standardLabelAP
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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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