🇺🇸 Xigduo XR in United States

FDA authorised Xigduo XR on 29 October 2014

Marketing authorisations

FDA — authorised 29 October 2014

  • Application: NDA205649
  • Marketing authorisation holder: ASTRAZENECA AB
  • Status: supplemented

FDA

  • Status: approved

Xigduo XR in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Xigduo XR approved in United States?

Yes. FDA authorised it on 29 October 2014; FDA has authorised it.

Who is the marketing authorisation holder for Xigduo XR in United States?

ASTRAZENECA AB holds the US marketing authorisation.