Last Updated: May 12, 2026

Details for New Drug Application (NDA): 210038

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NDA 210038 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 one supplier. 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 210038

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	2%
Approval Date:	Sep 22, 2020	TE:	AB	RLD:	No

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