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Details for New Drug Application (NDA): 021026

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NDA 021026 describes VUSION, which is a drug marketed by Delcor Asset Corp 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-seven 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 NDA: 021026

Pharmacology for NDA: 021026


Suppliers and Packaging for NDA: 021026

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
miconazole nitrate; petrolatum, white; zinc oxide
OINTMENT;TOPICAL 021026 NDA Prestium Pharma, Inc. 40076-002 40076-002-50 1 TUBE in 1 CARTON (40076-002-50) > 50 g in 1 TUBE
miconazole nitrate; petrolatum, white; zinc oxide
OINTMENT;TOPICAL 021026 NDA Physicians Total Care, Inc. 54868-6246 54868-6246-0 50 g in 1 TUBE (54868-6246-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.25%;81.35%;15%
Approval Date:Feb 16, 2006TE:RLD:Yes
Patent:8,147,852Patent Expiration:Mar 30, 2028Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021026

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Delcor Asset Corp
miconazole nitrate; petrolatum, white; zinc oxide
OINTMENT;TOPICAL021026-001Feb 16, 20064,911,932► subscribe
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