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Dow
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US Army
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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021026

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NDA 021026 describes VUSION, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the VUSION profile page.

The generic ingredient in VUSION is miconazole nitrate; petrolatum, white; zinc oxide. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the miconazole nitrate; petrolatum, white; zinc oxide profile page.
Summary for 021026
Tradename:VUSION
Applicant:Mylan Pharms Inc
Ingredient:miconazole nitrate; petrolatum, white; zinc oxide
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021026
Ingredient-typeAzoles
Suppliers and Packaging for NDA: 021026
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VUSION miconazole nitrate; petrolatum, white; zinc oxide OINTMENT;TOPICAL 021026 NDA Prestium Pharma, Inc. 40076-002 N 40076-002-50
VUSION miconazole nitrate; petrolatum, white; zinc oxide OINTMENT;TOPICAL 021026 NDA Physicians Total Care, Inc. 54868-6246 E 54868-6246-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.25%;81.35%;15%
Approval Date:Feb 16, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 30, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:USE FOR TREATMENT OF DIAPER DERMATITIS COMPLICATED BY CANDIDIASIS

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