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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 021812

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NDA 021812 describes WOMEN'S ROGAINE, which is a drug marketed by Kenvue Brands and is included in one NDA. It is available from one supplier. Additional details are available on the WOMEN'S ROGAINE profile page.

The generic ingredient in WOMEN'S ROGAINE is minoxidil. There are eight drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

Summary for 021812

Tradename:	WOMEN'S ROGAINE
Applicant:	Kenvue Brands
Ingredient:	minoxidil
Patents:	0

Pharmacology for NDA: 021812

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 021812

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 021812

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEN'S ROGAINE	minoxidil	AEROSOL, FOAM;TOPICAL	021812	NDA	Kenvue Brands LLC	69968-0030	69968-0030-1	1 CAN in 1 CARTON (69968-0030-1) / 60 g in 1 CAN
MEN'S ROGAINE	minoxidil	AEROSOL, FOAM;TOPICAL	021812	NDA	Kenvue Brands LLC	69968-0030	69968-0030-2	2 CAN in 1 CARTON (69968-0030-2) / 60 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	5%
Approval Date:	Jan 20, 2006	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	5%
Approval Date:	Feb 28, 2014	TE:		RLD:	Yes

Expired US Patents for NDA 021812

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	MEN'S ROGAINE	minoxidil	AEROSOL, FOAM;TOPICAL	021812-001	Jan 20, 2006	⤷ Get Started Free	⤷ Get Started Free
Kenvue Brands	WOMEN'S ROGAINE	minoxidil	AEROSOL, FOAM;TOPICAL	021812-002	Feb 28, 2014	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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