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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 071826

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NDA 071826 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 071826

Tradename:	MINOXIDIL
Applicant:	Ph Health
Ingredient:	minoxidil
Patents:	0

Pharmacology for NDA: 071826

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 071826

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 071826

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MINOXIDIL	minoxidil	TABLET;ORAL	071826	ANDA	Endo USA, Inc.	49884-256	49884-256-01	100 TABLET in 1 BOTTLE (49884-256-01)
MINOXIDIL	minoxidil	TABLET;ORAL	071826	ANDA	A-S Medication Solutions	50090-7758	50090-7758-0	90 TABLET in 1 BOTTLE (50090-7758-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Nov 14, 1988	TE:	AB	RLD:	No

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