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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 091344

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NDA 091344 describes MINOXIDIL, which is a drug marketed by Perrigo Pharma Intl, Ph Health, Royce Labs, Sun Pharm Industries, Usl Pharma, Watson Labs, Aurobindo Pharma, P And L, Taro, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Copley Pharm, Hikma, L Perrigo Co, Sight Pharms, Teva, Avacor Prods, Perrigo, and Perrigo New York, and is included in twenty-nine NDAs. It is available from twenty-six suppliers. Additional details are available on the MINOXIDIL profile page.

The generic ingredient in MINOXIDIL 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 091344

Tradename:	MINOXIDIL
Applicant:	Perrigo Pharma Intl
Ingredient:	minoxidil
Patents:	0

Pharmacology for NDA: 091344

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 091344

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 091344

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MINOXIDIL	minoxidil	AEROSOL, FOAM;TOPICAL	091344	ANDA	L. Perrigo Company	0113-1129	0113-1129-06	6 CAN in 1 CARTON (0113-1129-06) / 60 g in 1 CAN
MINOXIDIL	minoxidil	AEROSOL, FOAM;TOPICAL	091344	ANDA	L. Perrigo Company	0113-5129	0113-5129-01	60 g in 1 CAN (0113-5129-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	5%
Approval Date:	Apr 28, 2011	TE:		RLD:	No

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