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FDA NDA · NDA203567

JUBLIA

efinaconazole

Sponsor: BAUSCH

APPLICATION
NDA203567
TYPE
NDA
ORIGINAL APPROVAL
2014-06-06
LATEST ACTION
2022-03-31
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

JUBLIA · ReferencePrescription
EFINACONAZOLE 10% · SOLUTION · TOPICAL

Approval history

2022-03-31Labeling · Supplement 10 · standard — Letter ↗AP
2020-04-26Efficacy · Supplement 9 · standard — Letter ↗AP
2016-09-22Labeling · Supplement 6 · standard — Label ↗AP
2016-04-01Manufacturing (CMC) · Supplement 5 · standardAP
2015-11-05Manufacturing (CMC) · Supplement 4 · standardAP
2015-08-26Manufacturing (CMC) · Supplement 3 · standardAP
2015-02-27Labeling · Supplement 2 · standard — Label ↗AP
2014-06-06Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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