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Generated: November 13, 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 two suppliers. 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
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 Mylan Pharmaceuticals Inc. 0378-8136 0378-8136-01 100 g in 1 CAN (0378-8136-01)
EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738 NDA Mylan Pharmaceuticals Inc. 0378-8136 0378-8136-50 50 g in 1 CAN (0378-8136-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength2%
Approval Date:Jun 12, 2007TE:ATRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 19, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
Patent:➤ Try a Free TrialPatent 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

Expired US Patents for NDA 021738

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms Inc EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738-001 Jun 12, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc EXTINA ketoconazole AEROSOL, FOAM;TOPICAL 021738-001 Jun 12, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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