🇺🇸 Tesomet "Low dose" in fasted condition in United States

FDA authorised Tesomet "Low dose" in fasted condition on 30 November 1984

Marketing authorisations

FDA — authorised 30 November 1984

  • Application: NDA018883
  • Marketing authorisation holder: FRESENIUS MEDCL
  • Status: supplemented

FDA — authorised 31 January 2011

  • Application: ANDA200272
  • Marketing authorisation holder: ELITE LABS
  • Status: approved

FDA — authorised 31 January 2017

  • Application: ANDA207682
  • Marketing authorisation holder: MYLAN
  • Status: approved

FDA — authorised 3 June 2025

  • Application: ANDA217187
  • Marketing authorisation holder: PRECISION DOSE INC
  • Status: approved

Frequently asked questions

Is Tesomet "Low dose" in fasted condition approved in United States?

Yes. FDA authorised it on 30 November 1984; FDA authorised it on 31 January 2011; FDA authorised it on 31 January 2017.

Who is the marketing authorisation holder for Tesomet "Low dose" in fasted condition in United States?

FRESENIUS MEDCL holds the US marketing authorisation.