← FDA DRUG APPROVALS

FDA NDA · NDA021812

WOMENS ROGAINE UNSCENTED

minoxidil

Sponsor: KENVUE BRANDS

APPLICATION
NDA021812
TYPE
NDA
ORIGINAL APPROVAL
2006-01-20
LATEST ACTION
2026-01-14
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL, FOAM
MARKETING STATUS
Over-the-counter

Products

MEN'S ROGAINE · ReferenceOver-the-counter
MINOXIDIL 5% · AEROSOL, FOAM · TOPICAL
WOMEN'S ROGAINE · ReferenceOver-the-counter
MINOXIDIL 5% · AEROSOL, FOAM · TOPICAL

Approval history

2026-01-14Labeling · Supplement 20 · standard — Letter ↗AP
2020-12-29Labeling · Supplement 16 · standard — Letter ↗AP
2020-01-31Labeling · Supplement 15 · standard — Letter ↗AP
2019-06-11Labeling · Supplement 14 · standard — Letter ↗AP
2015-02-10Labeling · Supplement 11 · standard — Label ↗AP
2014-02-28Efficacy · Supplement 9 · standard — Letter ↗AP
2013-12-13Labeling · Supplement 10 · standard — Letter ↗AP
2012-11-30Manufacturing (CMC) · Supplement 8 · standardAP
2006-05-22Labeling · Supplement 1 · standard — Letter ↗AP
2006-01-20Type 3 - New Dosage Form · 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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