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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 206165

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NDA 206165 describes NAFTIFINE HYDROCHLORIDE, which is a drug marketed by Amneal, Sun Pharma Canada, 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. Four suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.

Summary for 206165

Tradename:	NAFTIFINE HYDROCHLORIDE
Applicant:	Amneal
Ingredient:	naftifine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	1%
Approval Date:	Mar 20, 2019	TE:	AB	RLD:	No

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