Details for New Drug Application (NDA): 208092

NDA 208092 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 208092

Tradename:	MINOXIDIL (FOR WOMEN)
Applicant:	P And L
Ingredient:	minoxidil
Patents:	0

Pharmacology for NDA: 208092

Physiological Effect

Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 208092

Antihypertensive Agents

Vasodilator Agents

Suppliers and Packaging for NDA: 208092

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MINOXIDIL (FOR MEN)	minoxidil	AEROSOL, FOAM;TOPICAL	208092	ANDA	Rite Aid Corporation	11822-0114	11822-0114-1	60 g in 1 CAN (11822-0114-1)
MINOXIDIL (FOR MEN)	minoxidil	AEROSOL, FOAM;TOPICAL	208092	ANDA	Rite Aid Corporation	11822-0114	11822-0114-2	2 CAN in 1 PACKAGE (11822-0114-2) / 60 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	5%
Approval Date:	Feb 17, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	AEROSOL, FOAM;TOPICAL			Strength	5%
Approval Date:	Jul 27, 2017	TE:		RLD:	No

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