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FDA NDA · NDA022404

ORAVIG

miconazole

Sponsor: GALT PHARMS

APPLICATION
NDA022404
TYPE
NDA
ORIGINAL APPROVAL
2010-04-16
LATEST ACTION
2020-02-04
ROUTE
BUCCAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ORAVIG · ReferencePrescription
MICONAZOLE 50MG · TABLET · BUCCAL

Approval history

2020-02-04Labeling · Supplement 5 · standard — Letter ↗AP
2013-03-05Labeling · Supplement 3 · standard — Label ↗AP
2011-04-08Labeling · Supplement 2 · standard — Label ↗AP
2010-04-16Type 3 - New Dosage Form · Original · standard — Label ↗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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