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Last Updated: December 7, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210038


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NDA 210038 describes NAFTIFINE HYDROCHLORIDE, which is a drug marketed by Taro Pharms, Tolmar, Xiromed, and Taro, and is included in six NDAs. It is available from three suppliers. Additional details are available on the NAFTIFINE HYDROCHLORIDE profile page.

The generic ingredient in NAFTIFINE HYDROCHLORIDE is naftifine hydrochloride. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
Summary for 210038
Tradename:NAFTIFINE HYDROCHLORIDE
Applicant:Xiromed
Ingredient:naftifine hydrochloride
Patents:0
Pharmacology for NDA: 210038
Suppliers and Packaging for NDA: 210038
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 210038 ANDA Xiromed, LLC 70700-161 70700-161-17 1 TUBE in 1 CARTON (70700-161-17) > 60 g in 1 TUBE
NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 210038 ANDA Xiromed, LLC 70700-161 70700-161-18 1 TUBE in 1 CARTON (70700-161-18) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.0%
Approval Date:Sep 22, 2020TE:ABRLD:No

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