← FDA Drug Approvals (Drugs@FDA)

XYREM

NDA · New Drug Application · Sponsor: JAZZ PHARMS · Approved 2002-07-17

Drug application

FDA Application #

NDA021196

Application type

New Drug Application

Brand name

XYREM

Generic name

SODIUM OXYBATE

Active ingredients

SODIUM OXYBATE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

JAZZ PHARMS

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2002-07-17

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown