Details for New Drug Application (NDA): 019356

✉ Email this page to a colleague

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

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.