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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 076239


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NDA 076239 describes THEROXIDIL, which is a drug marketed by Ei Inc and is included in two NDAs. It is available from seven 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the minoxidil profile page.
Summary for 076239
Tradename:THEROXIDIL
Applicant:Ei Inc
Ingredient:minoxidil
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076239
Suppliers and Packaging for NDA: 076239
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THEROXIDIL minoxidil SOLUTION;TOPICAL 076239 ANDA AVACOR PRODUCTS, LLC 49539-001 49539-001-01 3 BOTTLE in 1 CARTON (49539-001-01) > 60 mL in 1 BOTTLE
THEROXIDIL minoxidil SOLUTION;TOPICAL 076239 ANDA Pure Source, LLC 65121-101 65121-101-02 2 BOTTLE in 1 CARTON (65121-101-02) > 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;TOPICALStrength5%
Approval Date:Aug 24, 2004TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Express Scripts
Moodys
Dow
Boehringer Ingelheim

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