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Generated: November 13, 2018

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Details for New Drug Application (NDA): 020524

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NDA 020524 describes MENTAX, which is a drug marketed by Mylan and is included in two NDAs. It is available from one supplier. Additional details are available on the MENTAX profile page.

The generic ingredient in MENTAX is butenafine hydrochloride. There are two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the butenafine hydrochloride profile page.
Summary for 020524
Tradename:MENTAX
Applicant:Mylan
Ingredient:butenafine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020524
Ingredient-typeBenzylamines
Suppliers and Packaging for NDA: 020524
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MENTAX butenafine hydrochloride CREAM;TOPICAL 020524 NDA Mylan Pharmaceuticals Inc. 0378-6151 0378-6151-46 1 TUBE in 1 CARTON (0378-6151-46) > 15 g in 1 TUBE
MENTAX butenafine hydrochloride CREAM;TOPICAL 020524 NDA Mylan Pharmaceuticals Inc. 0378-6151 0378-6151-49 1 TUBE in 1 CARTON (0378-6151-49) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Oct 18, 1996TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Fish and Richardson
Mallinckrodt
Baxter
UBS
Cantor Fitzgerald
Chinese Patent Office
Merck
Boehringer Ingelheim

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