🇺🇸 NALOXONE HYDROCHLORIDE in United States

FDA authorised NALOXONE HYDROCHLORIDE on 22 October 1985

Marketing authorisations

FDA — authorised 22 October 1985

  • Application: ANDA070299
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 24 March 1988

  • Application: ANDA072076
  • Marketing authorisation holder: INTL MEDICATION
  • Status: supplemented

FDA — authorised 11 July 2001

  • Application: ANDA075735
  • Marketing authorisation holder: LUPIN
  • Status: supplemented

FDA — authorised 26 July 2017

  • Application: ANDA207634
  • Marketing authorisation holder: SOMERSET THERAPS LLC
  • Status: approved

FDA — authorised 8 August 2017

  • Application: ANDA207633
  • Marketing authorisation holder: SOMERSET THERAPS LLC
  • Status: approved

FDA

  • Status: approved

NALOXONE HYDROCHLORIDE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is NALOXONE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 22 October 1985; FDA authorised it on 24 March 1988; FDA authorised it on 11 July 2001.

Who is the marketing authorisation holder for NALOXONE HYDROCHLORIDE in United States?

HIKMA holds the US marketing authorisation.