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FDA NDA · NDA212379

AMZEEQ

minocycline

Sponsor: JOURNEY

APPLICATION
NDA212379
TYPE
NDA
ORIGINAL APPROVAL
2019-10-18
LATEST ACTION
2022-01-13
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Prescription

Products

AMZEEQ · ReferencePrescription
MINOCYCLINE HYDROCHLORIDE EQ 4% BASE · AEROSOL, FOAM · TOPICAL

Approval history

2022-01-13Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2021-01-29Labeling · Supplement 3 · standard — Label ↗AP
2019-10-18Type 3 - New Dosage Form · Original · standard — Label ↗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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