← FDA Drug Approvals (Drugs@FDA)

SPRAVATO

NDA · New Drug Application · Sponsor: JANSSEN PHARMS · Approved 2019-03-05

Drug application

FDA Application #

NDA211243

Application type

New Drug Application

Brand name

SPRAVATO

Generic name

ESKETAMINE HYDROCHLORIDE

Active ingredients

ESKETAMINE HYDROCHLORIDE

Dosage form

SPRAY

Route

NASAL

Marketing status

Prescription

Sponsor

JANSSEN PHARMS

Manufacturer

Janssen Pharmaceuticals Inc.

First approval

2019-03-05

Source

Authoritative

Drugs@FDA application overview

Machine

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