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Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
AstraZeneca
Accenture
Daiichi Sankyo
Express Scripts
Colorcon
Baxter
McKesson
US Department of Justice

Generated: October 17, 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 NDA: 019599

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antifungals

Pharmacology for NDA: 019599

Ingredient-typeAllylamine

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 0259-1102-02 10 TUBE in 1 CARTON (0259-1102-02) > 2 g in 1 TUBE
NAFTIN
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
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 Ltd
NAFTIN
naftifine hydrochloride
CREAM;TOPICAL019599-001Feb 29, 1988► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Teva
US Army
Dow
Cantor Fitzgerald
Express Scripts
Baxter
Accenture
Citi
Cerilliant

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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