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Generated: February 15, 2019

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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 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 076239
Applicant:Ei Inc
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 Bentley Laboratories, LLC 54111-205 54111-205-60 1 BOTTLE, PLASTIC in 1 CARTON (54111-205-60) > 60 mL in 1 BOTTLE, PLASTIC
THEROXIDIL minoxidil SOLUTION;TOPICAL 076239 ANDA Spencer Forrest, Inc. 61355-570 61355-570-60 1 BOTTLE, SPRAY in 1 CANISTER (61355-570-60) > 60 mL in 1 BOTTLE, SPRAY

Profile for product number 001

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

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