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Last Updated: November 25, 2020

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 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
Ingredient:miconazole nitrate; petrolatum, white; zinc oxide
Patents:1
Generic Entry Opportunity Date for 021026
Generic Entry Date for 021026*:
Constraining patent/regulatory exclusivity:
Dosage:
OINTMENT;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021026
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 AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-8222 0378-8222-50 1 TUBE in 1 CARTON (0378-8222-50) > 50 g in 1 TUBE
VUSION miconazole nitrate; petrolatum, white; zinc oxide OINTMENT;TOPICAL 021026 NDA Mylan Pharmaceuticals Inc. 0378-9730 0378-9730-50 1 TUBE in 1 CARTON (0378-9730-50) > 50 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.25%;81.35%;15%
Approval Date:Feb 16, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 30, 2028Product Flag?Substance Flag?Delist Request?

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