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FDA NDA · NDA213690

ZILXI

minocycline

Sponsor: JOURNEY

APPLICATION
NDA213690
TYPE
NDA
ORIGINAL APPROVAL
2020-05-28
LATEST ACTION
2024-02-20
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Prescription

Products

ZILXI · ReferencePrescription
MINOCYCLINE HYDROCHLORIDE EQ 1.5% BASE · AEROSOL, FOAM · TOPICAL

Approval history

2024-02-20Manufacturing (CMC) · Supplement 9LabelAP
2020-05-28Type 5 - New Formulation or New Manufacturer · Original · standardLabelAP
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