← FDA DRUG APPROVALS

FDA NDA · NDA217603

XDEMVY

lotilaner ophthalmic solution

Sponsor: TARSUS

APPLICATION
NDA217603
TYPE
NDA
ORIGINAL APPROVAL
2023-07-24
LATEST ACTION
2023-07-24
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

XDEMVY · ReferencePrescription
LOTILANER 0.25% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2023-07-24Type 1 - New Molecular Entity · 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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