🇺🇸 Zoladex in United States

FDA authorised Zoladex on 29 December 1989

Marketing authorisations

FDA — authorised 29 December 1989

  • Application: NDA019726
  • Marketing authorisation holder: TERSERA
  • Status: supplemented

FDA — authorised 11 January 1996

  • Application: NDA020578
  • Marketing authorisation holder: TERSERA
  • Status: supplemented

FDA

  • Status: approved

Other Oncology approved in United States

Frequently asked questions

Is Zoladex approved in United States?

Yes. FDA authorised it on 29 December 1989; FDA authorised it on 11 January 1996; FDA has authorised it.

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

TERSERA holds the US marketing authorisation.