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FDA NDA · NDA204153

LUZU

luliconazole

Sponsor: BAUSCH

APPLICATION
NDA204153
TYPE
NDA
ORIGINAL APPROVAL
2013-11-14
LATEST ACTION
2018-02-20
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

LUZU · ReferencePrescription
LULICONAZOLE 1% · CREAM · TOPICAL

Approval history

2018-02-20Efficacy · Supplement 4 · standard — Label ↗AP
2018-02-20Efficacy · Supplement 5 · standard — Label ↗AP
2017-02-08Labeling · Supplement 2 · standard — Letter ↗AP
2016-06-07Manufacturing (CMC) · Supplement 1 · standardAP
2013-11-14Type 1 - New Molecular Entity · Original · standard — Review ↗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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