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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 208201


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NDA 208201 describes NAFTIFINE HYDROCHLORIDE, which is a drug marketed by Amneal, Taro, and Xiromed, and is included in six NDAs. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
Summary for 208201
Tradename:NAFTIFINE HYDROCHLORIDE
Applicant:Taro
Ingredient:naftifine hydrochloride
Patents:0
Pharmacology for NDA: 208201
Suppliers and Packaging for NDA: 208201
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFTIFINE HYDROCHLORIDE naftifine hydrochloride GEL;TOPICAL 208201 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1376 51672-1376-3 1 TUBE in 1 CARTON (51672-1376-3) / 60 g in 1 TUBE
NAFTIFINE HYDROCHLORIDE naftifine hydrochloride GEL;TOPICAL 208201 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1376 51672-1376-6 1 TUBE in 1 CARTON (51672-1376-6) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2%
Approval Date:Apr 10, 2019TE:ABRLD:No

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