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FDA NDA · NDA220442

XOCOVA

ensitrelvir

Sponsor: SHIONOGI

APPLICATION
NDA220442
TYPE
NDA
ORIGINAL APPROVAL
2026-05-29
LATEST ACTION
2026-05-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XOCOVA · ReferencePrescription
ENSITRELVIR 125MG · TABLET · ORAL

Approval history

2026-05-29Type 1 - New Molecular Entity · Original · standardLabelAP
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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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