← FDA DRUG APPROVALS

FDA NDA · NDA021026

VUSION

miconazole nitrate, zinc oxide, white petrolatum

Sponsor: MYLAN

APPLICATION
NDA021026
TYPE
NDA
ORIGINAL APPROVAL
2006-02-16
LATEST ACTION
2018-08-29
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

VUSION · ReferencePrescription
MICONAZOLE NITRATE 0.25%, WHITE PETROLATUM 81.35%, ZINC OXIDE 15% · OINTMENT · TOPICAL

Approval history

2018-08-29Labeling · Supplement 13 · standard — Label ↗AP
2016-06-16Manufacturing (CMC) · Supplement 12 · standardAP
2014-05-21Manufacturing (CMC) · Supplement 11 · standardAP
2010-04-01Labeling · Supplement 6 · standard — Letter ↗AP
2007-10-03Labeling · Supplement 4 · standard — Letter ↗AP
2006-02-16Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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