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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 205975


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NDA 205975 describes NAFTIFINE HYDROCHLORIDE, which is a drug marketed by Amneal, Taro, and Xiromed, 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 205975
Tradename:NAFTIFINE HYDROCHLORIDE
Applicant:Taro
Ingredient:naftifine hydrochloride
Patents:0
Pharmacology for NDA: 205975
Suppliers and Packaging for NDA: 205975
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 205975 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1362 51672-1362-1 1 TUBE in 1 CARTON (51672-1362-1) / 15 g in 1 TUBE
NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 205975 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1362 51672-1362-2 1 TUBE in 1 CARTON (51672-1362-2) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Sep 8, 2016TE:RLD:No

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