← FDA DRUG APPROVALS

FDA NDA · NDA020834

MENS ROGAINE EXTRA STRENGTH UNSCENTED

minoxidil

Sponsor: KENVUE BRANDS

APPLICATION
NDA020834
TYPE
NDA
ORIGINAL APPROVAL
1997-11-14
LATEST ACTION
2026-01-14
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

ROGAINE EXTRA STRENGTH (FOR MEN) · ReferenceOver-the-counter
MINOXIDIL 5% · SOLUTION · TOPICAL

Approval history

2026-01-14Labeling · Supplement 21 · standard — Letter ↗AP
2015-04-27Labeling · Supplement 14 · standard — Label ↗AP
2006-09-12Labeling · Supplement 11 · standard — Letter ↗AP
2005-05-31Labeling · Supplement 9 · standard — Letter ↗AP
2004-06-25Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2003-02-14Labeling · Supplement 3 · standard — Letter ↗AP
1998-04-16Manufacturing (CMC) · Supplement 1 · standardAP
1997-11-14Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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