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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 Merz Pharms 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. Four suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.

Summary for NDA: 019599

Merz Pharms
naftifine hydrochloride
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
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
naftifine hydrochloride
CREAM;TOPICAL 019599 NDA Merz Pharmaceuticals, LLC 0259-1102 0259-1102-30 1 TUBE in 1 CARTON (0259-1102-30) > 30 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

Expired Orange Book Patents for NDA: 019599

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merz Pharms
naftifine hydrochloride
CREAM;TOPICAL019599-001Feb 29, 19884,282,251<disabled>
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