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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 019599


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NDA 019599 describes NAFTIN, which is a drug marketed by Sebela Ireland Ltd and is included in three NDAs. It is available from two 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. Four suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
Summary for 019599
Tradename:NAFTIN
Applicant:Sebela Ireland Ltd
Ingredient:naftifine hydrochloride
Patents:0
Pharmacology for NDA: 019599
Suppliers and Packaging for NDA: 019599
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599 NDA Renaissance Pharma, Inc. 40085-203 40085-203-45 1 TUBE in 1 CARTON (40085-203-45) > 45 g in 1 TUBE
NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599 NDA Renaissance Pharma, Inc. 40085-203 40085-203-60 1 TUBE in 1 CARTON (40085-203-60) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength1%
Approval Date:Feb 29, 1988TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2%
Approval Date:Jan 13, 2012TE:ABRLD:Yes

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