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FDA NDA · NDA219474

ADQUEY

difamilast

Sponsor: ACROTECH BIOPHARMA

APPLICATION
NDA219474
TYPE
NDA
ORIGINAL APPROVAL
2026-02-12
LATEST ACTION
2026-02-12
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

ADQUEY · ReferencePrescription
DIFAMILAST 1% · OINTMENT · TOPICAL

Approval history

2026-02-12Type 1 - New Molecular Entity · Original · standardLetterAP
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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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