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Last Updated: December 21, 2024

Details for New Drug Application (NDA): 071344


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NDA 071344 describes MINOXIDIL, which is a drug marketed by Perrigo Pharma Intl, Endo Operations, 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-seven NDAs. It is available from twenty-eight 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. One hundred and five suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 071344
Tradename:MINOXIDIL
Applicant:Watson Labs
Ingredient:minoxidil
Patents:0
Pharmacology for NDA: 071344
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 071344
Suppliers and Packaging for NDA: 071344
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOXIDIL minoxidil TABLET;ORAL 071344 ANDA Actavis Pharma, Inc. 0591-5642 0591-5642-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5642-01)
MINOXIDIL minoxidil TABLET;ORAL 071344 ANDA Actavis Pharma, Inc. 0591-5642 0591-5642-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-5642-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Mar 3, 1987TE:ABRLD:No

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