← FDA Drug Approvals (Drugs@FDA)

LUNESTA

NDA · New Drug Application · Sponsor: WAYLIS THERAP · Approved 2004-12-15

Drug application

FDA Application #

NDA021476

Application type

New Drug Application

Brand name

LUNESTA

Generic name

ESZOPICLONE

Active ingredients

ESZOPICLONE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

WAYLIS THERAP

Manufacturer

Waylis Therapeutics LLC

First approval

2004-12-15

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown