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REXTOVY

NDA · New Drug Application · Sponsor: AMPHASTAR PHARMS INC · Approved 2023-03-07

Drug application

FDA Application #

NDA208969

Application type

New Drug Application

Brand name

REXTOVY

Generic name

NALOXONE HYDROCHLORIDE

Active ingredients

NALOXONE HYDROCHLORIDE

Dosage form

SPRAY, METERED

Route

NASAL

Marketing status

Prescription

Sponsor

AMPHASTAR PHARMS INC

Manufacturer

International Medication Systems, Ltd.

First approval

2023-03-07

Source

Authoritative

Drugs@FDA application overview

Machine

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