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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 075518


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NDA 075518 describes MINOXIDIL EXTRA STRENGTH (FOR MEN), which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Avacor Prods, P And L, Perrigo, and Perrigo New York, and is included in six NDAs. It is available from twenty-nine suppliers. Additional details are available on the MINOXIDIL EXTRA STRENGTH (FOR MEN) profile page.

The generic ingredient in MINOXIDIL EXTRA STRENGTH (FOR MEN) 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 075518
Tradename:MINOXIDIL EXTRA STRENGTH (FOR MEN)
Applicant:P And L
Ingredient:minoxidil
Patents:0
Pharmacology for NDA: 075518
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 075518
Suppliers and Packaging for NDA: 075518
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075518 ANDA Walgreens 0363-9971 0363-9971-02 1 BOTTLE, DROPPER in 1 CARTON (0363-9971-02) / 60 mL in 1 BOTTLE, DROPPER
MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075518 ANDA Walgreens 0363-9971 0363-9971-06 3 BOTTLE, DROPPER in 1 BOTTLE (0363-9971-06) / 60 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength5%
Approval Date:Nov 17, 2000TE:RLD:No

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