🇺🇸 adrenalin in United States

FDA authorised adrenalin on 7 December 2012

Marketing authorisations

FDA — authorised 7 December 2012

  • Application: NDA204200
  • Marketing authorisation holder: PH HEALTH
  • Status: supplemented

FDA — authorised 18 December 2013

  • Application: NDA204640
  • Marketing authorisation holder: PH HEALTH
  • Status: supplemented

FDA — authorised 21 April 2023

  • Application: NDA215875
  • Marketing authorisation holder: PH HEALTH
  • Status: supplemented

FDA

  • Status: approved

Other Nephrology approved in United States

Frequently asked questions

Is adrenalin approved in United States?

Yes. FDA authorised it on 7 December 2012; FDA authorised it on 18 December 2013; FDA authorised it on 21 April 2023.

Who is the marketing authorisation holder for adrenalin in United States?

PH HEALTH holds the US marketing authorisation.