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Generated: May 26, 2017

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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 NDA: 204286

Therapeutic Class:Antifungals

Pharmacology for NDA: 204286


Suppliers and Packaging for NDA: 204286

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naftifine hydrochloride
GEL;TOPICAL 204286 NDA Merz Pharmaceuticals, LLC 0259-1202 0259-1202-45 1 TUBE in 1 CARTON (0259-1202-45) > 45 g in 1 TUBE
naftifine hydrochloride
GEL;TOPICAL 204286 NDA Merz Pharmaceuticals, LLC 0259-1202 0259-1202-60 1 TUBE in 1 CARTON (0259-1202-60) > 60 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2%
Approval Date:Jun 27, 2013TE:RLD:Yes
Patent:8,778,365Patent Expiration:Jan 31, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:9,161,914Patent Expiration:Jan 31, 2033Product Flag?Substance Flag?Delist Request?

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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 verifification 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.

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