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FDA NDA · NDA215888

VIVJOA

oteseconazole

Sponsor: MYCOVIA PHARMS

APPLICATION
NDA215888
TYPE
NDA
ORIGINAL APPROVAL
2022-04-26
LATEST ACTION
2024-04-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

VIVJOA · ReferencePrescription
OTESECONAZOLE 150MG · CAPSULE · ORAL

Approval history

2024-04-11Labeling · Supplement 2 · standardLabelAP
2022-04-26Type 1 - New Molecular Entity · Original · priorityLetterAP
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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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