🇺🇸 Naloxone Hydrochloride Injection, USP in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Naloxone Hydrochloride Injection, USP on 28 February 2022

Marketing authorisation

FDA — authorised 28 February 2022

Application: NDA215457
Marketing authorisation holder: KALEO INC
Status: supplemented

Frequently asked questions

Is Naloxone Hydrochloride Injection, USP approved in United States?

Yes. FDA authorised it on 28 February 2022.

Who is the marketing authorisation holder for Naloxone Hydrochloride Injection, USP in United States?

KALEO INC holds the US marketing authorisation.