Details for New Drug Application (NDA): 019356

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NDA 019356 describes NAFTIN, which is a drug marketed by Sebela Ireland Ltd 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 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 019356

Tradename:	NAFTIN
Applicant:	Sebela Ireland Ltd
Ingredient:	naftifine hydrochloride
Patents:	0

Pharmacology for NDA: 019356

Suppliers and Packaging for NDA: 019356

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356	NDA	Sebela Pharmaceuticals Inc.	54766-770	54766-770-40	1 TUBE in 1 CARTON (54766-770-40) / 40 g in 1 TUBE
NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356	NDA	Sebela Pharmaceuticals Inc.	54766-770	54766-770-60	1 TUBE in 1 CARTON (54766-770-60) / 60 g in 1 TUBE

Profile for product number 001

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

Expired US Patents for NDA 019356

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	⤷ Subscribe	⤷ Subscribe
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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