APPLICATION
NDA019501
TYPE
NDA
ORIGINAL APPROVAL
1988-08-17
LATEST ACTION
2026-01-14
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter
Products
ROGAINE (FOR WOMEN) · ReferenceOver-the-counter
MINOXIDIL 2% · SOLUTION · TOPICAL
ROGAINE (FOR MEN) · ReferenceOver-the-counter
MINOXIDIL 2% · SOLUTION · TOPICAL
Approval history
2016-05-24Manufacturing (CMC) · Supplement 30 · priorityAP
1998-04-16Manufacturing (CMC) · Supplement 16 · priorityAP
1996-03-11Manufacturing (CMC) · Supplement 14 · priorityAP
1996-02-09Efficacy · Supplement 12 · unknownAP
1994-12-01Labeling · Supplement 13 · standardAP
1994-04-08Labeling · Supplement 8AP
1993-07-28Labeling · Supplement 11 · standardAP
1993-07-28Labeling · Supplement 10 · standardAP
1992-09-24Labeling · Supplement 9AP
1991-08-13Efficacy · Supplement 3AP
1990-10-05Labeling · Supplement 7AP
1990-03-23Labeling · Supplement 4AP
1990-02-23Labeling · Supplement 6AP
1990-02-12Manufacturing (CMC) · Supplement 5 · priorityAP
1989-09-19Labeling · Supplement 2AP
1988-08-24Labeling · Supplement 1AP
1988-08-17Type 3 - New Dosage Form · Original · priorityAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.