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FDA NDA · NDA217469

VEVYE

cyclosporine ophthalmic solution

Sponsor: HARROW EYE

APPLICATION
NDA217469
TYPE
NDA
ORIGINAL APPROVAL
2023-05-30
LATEST ACTION
2025-09-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VEVYE · ReferencePrescription
CYCLOSPORINE 0.1% · SOLUTION · OPHTHALMIC

Approval history

2025-09-18Labeling · Supplement 7 · standard — Letter ↗AP
2024-05-28Labeling · Supplement 3 · standard — Letter ↗AP
2023-05-30Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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