Last Updated: May 3, 2026

Details for New Drug Application (NDA): 075438

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NDA 075438 describes MINOXIDIL EXTRA STRENGTH (FOR MEN), which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Avacor Prods, P And L, Perrigo, Perrigo New York, and Taro, and is included in seven NDAs. It is available from twenty-four suppliers. Additional details are available on the MINOXIDIL EXTRA STRENGTH (FOR MEN) profile page.

The generic ingredient in MINOXIDIL EXTRA STRENGTH (FOR MEN) is minoxidil. There are eight drug master file entries for this compound. Seventy-nine suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

Summary for 075438

Tradename:	MINOXIDIL EXTRA STRENGTH (FOR MEN)
Applicant:	Aurobindo Pharma Ltd
Ingredient:	minoxidil
Patents:	0

Pharmacology for NDA: 075438

Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 075438

Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 075438

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MINOXIDIL EXTRA STRENGTH (FOR MEN)	minoxidil	SOLUTION;TOPICAL	075438	ANDA	FlexiGo Inc	85524-2625	85524-2625-2	1 BOTTLE in 1 BOX (85524-2625-2) / 30 mL in 1 BOTTLE (85524-2625-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION;TOPICAL			Strength	5%
Approval Date:	Feb 27, 2003	TE:		RLD:	No

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