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NALOXONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: STERINOVA INC · Approved 2025-08-21

Drug application

FDA Application #

ANDA214211

Application type

Abbreviated New Drug Application (Generic)

Brand name

NALOXONE HYDROCHLORIDE

Generic name

NALOXONE HYDROCHLORIDE

Active ingredients

NALOXONE HYDROCHLORIDE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

STERINOVA INC

Manufacturer

Meitheal Pharmaceuticals Inc.

First approval

2025-08-21

Source

Authoritative

Drugs@FDA application overview

Machine

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