Last Updated: May 9, 2026

Details for New Drug Application (NDA): 071345

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NDA 071345 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-three 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 suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

Summary for 071345

Tradename:	MINOXIDIL
Applicant:	Watson Labs
Ingredient:	minoxidil
Patents:	0

Pharmacology for NDA: 071345

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 071345

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 071345

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MINOXIDIL	minoxidil	TABLET;ORAL	071345	ANDA	Actavis Pharma, Inc.	0591-5643	0591-5643-01	100 TABLET in 1 BOTTLE, PLASTIC (0591-5643-01)
MINOXIDIL	minoxidil	TABLET;ORAL	071345	ANDA	Actavis Pharma, Inc.	0591-5643	0591-5643-05	500 TABLET in 1 BOTTLE, PLASTIC (0591-5643-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 3, 1987	TE:	AB	RLD:	No

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