🇺🇸 Primatene Mist in United States

FDA authorised Primatene Mist on 7 November 2018

Marketing authorisation

FDA — authorised 7 November 2018

  • Application: NDA205920
  • Marketing authorisation holder: ARMSTRONG PHARMS
  • Status: approved

Other Respiratory approved in United States

Frequently asked questions

Is Primatene Mist approved in United States?

Yes. FDA authorised it on 7 November 2018.

Who is the marketing authorisation holder for Primatene Mist in United States?

ARMSTRONG PHARMS holds the US marketing authorisation.