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Serving leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office

Generated: December 15, 2017

DrugPatentWatch Database Preview

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 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 019599

Therapeutic Class:Antifungals

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 Merz Pharmaceuticals, LLC 0259-1102 0259-1102-45 1 TUBE in 1 CARTON (0259-1102-45) > 45 g in 1 TUBE
NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599 NDA Merz Pharmaceuticals, LLC 0259-1102 0259-1102-02 10 TUBE in 1 CARTON (0259-1102-02) > 2 g in 1 TUBE

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2%
Approval Date:Jan 13, 2012TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Nov 10, 2019
Regulatory Exclusivity Use:

Expired Orange Book Patents for NDA: 019599

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland LtdNAFTINnaftifine hydrochlorideCREAM;TOPICAL019599-001Feb 29, 1988► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Chinese Patent Office
Federal Trade Commission
Daiichi Sankyo
Fish and Richardson

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