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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

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 three suppliers. There are four 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. Five 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:RXDosage:GEL;TOPICALStrength1%
Approval Date:Jun 18, 1990TE:ABRLD:Yes

Expired US Patents for NDA 019356

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

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