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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 091344


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NDA 091344 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-nine 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 091344
Tradename:MINOXIDIL
Applicant:Perrigo Pharma Intl
Ingredient:minoxidil
Patents:0
Pharmacology for NDA: 091344
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 091344
Suppliers and Packaging for NDA: 091344
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOXIDIL minoxidil AEROSOL, FOAM;TOPICAL 091344 ANDA L. Perrigo Company 0113-1129 0113-1129-06 6 CAN in 1 CARTON (0113-1129-06) / 60 g in 1 CAN
MINOXIDIL minoxidil AEROSOL, FOAM;TOPICAL 091344 ANDA L. Perrigo Company 0113-5129 0113-5129-01 60 g in 1 CAN (0113-5129-01)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, FOAM;TOPICALStrength5%
Approval Date:Apr 28, 2011TE:RLD:No

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