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Generated: December 16, 2018

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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 three 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. Five 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
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:RXDosage:GEL;TOPICALStrength2%
Approval Date:Jun 27, 2013TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 31, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 31, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS

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