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Generated: January 20, 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-six 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 40076-051-50 50 g in 1 CAN (40076-051-50)
EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738 NDA Prestium Pharma, Inc. 40076-051 40076-051-00 100 g in 1 CAN (40076-051-00)

Profile for product number 001

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

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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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