Orange Book product · Brand (NDA)

VUSION

MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE

Brand (NDA)NDA 021026RX MYLAN

Feb 16, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 16, 2006
20 yr 8 mo ago
Today
Patent 8147852 expires
Listed method-of-use patent (U-1426) expiration.
Mar 30, 2028
in 1 yr 10 mo

Active ingredient

MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE

Strength

0.25%;81.35%;15%

Dosage form

OINTMENT

Route

TOPICAL

TE code

Not listed

Application

NDA 021026

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8147852	Mar 30, 2028	in 1 yr 10 mo	U-1426