Last Updated: November 13, 2026

Details for New Drug Application (NDA): 210038

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 is one drug master file entry for this compound. Two 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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