🇺🇸 xopenex in United States

FDA authorised xopenex on 11 March 2005

Marketing authorisations

FDA — authorised 11 March 2005

  • Application: NDA021730
  • Marketing authorisation holder: LUPIN
  • Status: supplemented

FDA

  • Status: approved

Other Respiratory approved in United States

Frequently asked questions

Is xopenex approved in United States?

Yes. FDA authorised it on 11 March 2005; FDA has authorised it.

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

LUPIN holds the US marketing authorisation.