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XOCOVA

NDA · New Drug Application · Sponsor: SHIONOGI · Approved 2026-05-29

Drug application

FDA Application #

NDA220442

Application type

New Drug Application

Brand name

XOCOVA

Generic name

ENSITRELVIR

Active ingredients

ENSITRELVIR

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

SHIONOGI

Manufacturer

Shionogi Inc.

First approval

2026-05-29

Source

Authoritative

Drugs@FDA application overview

Machine

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