Details for New Drug Application (NDA): 072709

NDA 072709 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-one suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

Summary for 072709

Tradename:	MINOXIDIL
Applicant:	Sun Pharm Industries
Ingredient:	minoxidil
Patents:	0

Pharmacology for NDA: 072709

Physiological Effect

Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for 072709

Antihypertensive Agents

Vasodilator Agents

Suppliers and Packaging for NDA: 072709

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MINOXIDIL	minoxidil	TABLET;ORAL	072709	ANDA	Sun Pharmaceutical Industries, Inc.	53489-386	53489-386-01	100 TABLET in 1 BOTTLE (53489-386-01)
MINOXIDIL	minoxidil	TABLET;ORAL	072709	ANDA	Sun Pharmaceutical Industries, Inc.	53489-386	53489-386-03	250 TABLET in 1 BOTTLE (53489-386-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 14, 1995	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Dec 14, 1995	TE:	AB	RLD:	No

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