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Generated: February 19, 2019

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Details for New Drug Application (NDA): 078176

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NDA 078176 describes THEROXIDIL, which is a drug marketed by Ei Inc and is included in two NDAs. It is available from nine suppliers. Additional details are available on the THEROXIDIL profile page.

The generic ingredient in THEROXIDIL is minoxidil. There are eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 078176
Tradename:THEROXIDIL
Applicant:Ei Inc
Ingredient:minoxidil
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078176
Suppliers and Packaging for NDA: 078176
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEROXIDIL minoxidil SOLUTION;TOPICAL 078176 ANDA Walgreens 0363-2173 0363-2173-05 3 BOTTLE in 1 PACKAGE (0363-2173-05) > 60 mL in 1 BOTTLE
THEROXIDIL minoxidil SOLUTION;TOPICAL 078176 ANDA Walgreens 0363-2173 0363-2173-02 1 BOTTLE in 1 PACKAGE (0363-2173-02) > 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength2%
Approval Date:Nov 9, 2007TE:RLD:No

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