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Last Updated: November 17, 2024

Details for New Drug Application (NDA): 075598


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NDA 075598 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 075598
Tradename:MINOXIDIL EXTRA STRENGTH (FOR MEN)
Applicant:Perrigo
Ingredient:minoxidil
Patents:0
Pharmacology for NDA: 075598
Physiological EffectArteriolar Vasodilation
Medical Subject Heading (MeSH) Categories for 075598
Suppliers and Packaging for NDA: 075598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075598 ANDA L. Perrigo Company 0113-0798 0113-0798-30 3 BOTTLE in 1 CARTON (0113-0798-30) / 60 mL in 1 BOTTLE
MINOXIDIL EXTRA STRENGTH (FOR MEN) minoxidil SOLUTION;TOPICAL 075598 ANDA L. Perrigo Company 0113-0798 0113-0798-40 6 BOTTLE in 1 CARTON (0113-0798-40) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength5%
Approval Date:Jun 13, 2001TE:RLD:No

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