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FDA NDA · NDA207795

VYZULTA

latanoprostene bunod

Sponsor: BAUSCH AND LOMB

APPLICATION
NDA207795
TYPE
NDA
ORIGINAL APPROVAL
2017-11-02
LATEST ACTION
2018-06-11
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

VYZULTA · ReferencePrescription
LATANOPROSTENE BUNOD 0.024% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2018-06-11Labeling · Supplement 2 · standard — Letter ↗AP
2017-11-02Type 1 - New Molecular Entity · 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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