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LUMRYZ

NDA · New Drug Application · Sponsor: AVADEL CNS · Approved 2023-05-01

Drug application

FDA Application #

NDA214755

Application type

New Drug Application

Brand name

LUMRYZ

Generic name

SODIUM OXYBATE

Active ingredients

SODIUM OXYBATE

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

AVADEL CNS

Manufacturer

Avadel CNS Pharmaceuticals, LLC

First approval

2023-05-01

Source

Authoritative

Drugs@FDA application overview

Machine

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