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Julphar
US Department of Justice
Merck
Harvard Business School
Chinese Patent Office
Fuji
Cantor Fitzgerald
Express Scripts
Chubb

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021738

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NDA 021738 describes EXTINA, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EXTINA profile page.

The generic ingredient in EXTINA is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 021738
Tradename:EXTINA
Applicant:Mylan Pharms Inc
Ingredient:ketoconazole
Patents:2
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 021738
Medical Subject Heading (MeSH) Categories for 021738
Suppliers and Packaging for NDA: 021738
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738 NDA Prestium Pharma, Inc. 40076-051 N 40076-051-00
EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738 NDA Prestium Pharma, Inc. 40076-051 N 40076-051-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength2%
Approval Date:Jun 12, 2007TE:ATRLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 19, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
Patent:➤ Sign UpPatent Expiration:Oct 19, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN IMMUNOCOMPETENT PATIENTS 12 YEARS OF AGE AND OLDER

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Healthtrust
Express Scripts
Cantor Fitzgerald
Citi
Julphar
Cerilliant
Boehringer Ingelheim
Covington

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