Details for New Drug Application (NDA): 218616

NDA 218616 describes MINOXIDIL (FOR WOMEN), which is a drug marketed by Aurobindo Pharma, P And L, Taro, Apotex Inc, Hikma, L Perrigo Co, and Sight Pharms, and is included in seven NDAs. It is available from forty-two suppliers. Additional details are available on the MINOXIDIL (FOR WOMEN) profile page.

The generic ingredient in MINOXIDIL (FOR WOMEN) is minoxidil. There are eight drug master file entries for this compound. One hundred and five suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

Summary for 218616

Tradename:	MINOXIDIL (FOR WOMEN)
Applicant:	Aurobindo Pharma
Ingredient:	minoxidil
Patents:	0

Pharmacology for NDA: 218616

Physiological Effect

Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 218616

Antihypertensive Agents

Vasodilator Agents

Suppliers and Packaging for NDA: 218616

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MINOXIDIL (FOR MEN)	minoxidil	AEROSOL, FOAM;TOPICAL	218616	ANDA	Aurohealth LLC	58602-607	58602-607-01	1 CAN in 1 CARTON (58602-607-01) / 60 g in 1 CAN
MINOXIDIL (FOR MEN)	minoxidil	AEROSOL, FOAM;TOPICAL	218616	ANDA	Aurohealth LLC	58602-607	58602-607-02	2 CAN in 1 CARTON (58602-607-02) / 60 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	5%
Approval Date:	Apr 22, 2024	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	5%
Approval Date:	Apr 22, 2024	TE:		RLD:	No

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