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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204286

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NDA 204286 describes NAFTIN, which is a drug marketed by Sebela Ireland Ltd and is included in three NDAs. It is available from four suppliers. There are two 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. Six 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:2
Therapeutic Class:Antifungals
Pharmacology for NDA: 204286
Ingredient-typeAllylamine
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 Merz Pharmaceuticals, LLC 0259-1202 N 0259-1202-45
NAFTIN naftifine hydrochloride GEL;TOPICAL 204286 NDA Merz Pharmaceuticals, LLC 0259-1202 N 0259-1202-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2%
Approval Date:Jun 27, 2013TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 31, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 31, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS

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