Last Updated: November 13, 2026

Details for New Drug Application (NDA): 019356

NDA 019356 describes NAFTIN, which is a drug marketed by Legacy and is included in three NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAFTIN profile page.

The generic ingredient in NAFTIN 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 019356

Tradename:	NAFTIN
Applicant:	Legacy
Ingredient:	naftifine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TOPICAL			Strength	1%
Approval Date:	Jun 18, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019356

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	4,282,251	⤷ Start Trial
Legacy	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	4,828,251	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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