Details for New Drug Application (NDA): 204286

NDA 204286 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 204286

Tradename:	NAFTIN
Applicant:	Sebela Ireland Ltd
Ingredient:	naftifine hydrochloride
Patents:	6

Pharmacology for NDA: 204286

Suppliers and Packaging for NDA: 204286

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286	NDA	Sebela Pharmaceuticals Inc.	54766-772	54766-772-45	1 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBE
NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286	NDA	Sebela Pharmaceuticals Inc.	54766-772	54766-772-60	1 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	2%
Approval Date:	Jun 27, 2013	TE:	AB	RLD:	Yes
Patent:	10,166,205	Patent Expiration:	Jan 31, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,166,206	Patent Expiration:	Jan 31, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,695,303	Patent Expiration:	Jan 31, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Complete Access Available with Subscription