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 one supplier. There is one patent protecting this drug. Additional details are available on the VUSION profile page.

The generic ingredient in VUSION is miconazole nitrate; white petrolatum; zinc oxide. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the miconazole nitrate; white petrolatum; zinc oxide profile page.

Summary for 021026

Tradename:	VUSION
Applicant:	Mylan
Ingredient:	miconazole nitrate; white petrolatum; zinc oxide
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021026

Generic Entry Date for 021026^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 4,911,932 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; white petrolatum; 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; white petrolatum; 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:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.25%;81.35%;15%
Approval Date:	Feb 16, 2006	TE:		RLD:	Yes
Patent:	8,147,852	Patent Expiration:	Mar 30, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE FOR TREATMENT OF DIAPER DERMATITIS COMPLICATED BY CANDIDIASIS

Expired US Patents for NDA 021026

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	VUSION	miconazole nitrate; white petrolatum; zinc oxide	OINTMENT;TOPICAL	021026-001	Feb 16, 2006	4,911,932	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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