Vusion

Treats diaper dermatitis. NDA 21026, held by Mylan. Miconazole Nitrate; White Petrolatum; Zinc Oxide.

As of Nov 14, 2026, NDA 21026 (Vusion), held by Mylan, was first approved by FDA on Feb 16, 2006, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 16, 2006
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Miconazole nitrate, zinc oxide and white petrolatum ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) in immunocompetent pediatric patients 4 weeks and older.
Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used as a substitute for frequent diaper changes.
Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 16, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vusion0.25%;81.35%;15% · ointment;topical	Miconazole Nitrate; White Petrolatum; Zinc Oxide	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Aug 29, 2018	Supplement 13Labeling · Standard review	Approved	Label
Jun 16, 2016	Supplement 12Manufacturing · Standard review	Approved	None posted
May 21, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 1, 2010	Supplement 6Labeling · Standard review	Approved	Label Letter
Oct 3, 2007	Supplement 4Labeling · Standard review	Approved	Label Letter
Feb 16, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21026
Drugs@FDA: Overview at FDA
Company: Mylan

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters