🇺🇸 Extraneal in United States

FDA authorised Extraneal on 20 December 2002

Marketing authorisations

FDA — authorised 20 December 2002

  • Marketing authorisation holder: BAXTER HLTHCARE
  • Status: approved

FDA — authorised 20 December 2002

  • Application: NDA021321
  • Marketing authorisation holder: VANTIVE US HLTHCARE
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

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Extraneal in other countries

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

Other Respiratory approved in United States

Frequently asked questions

Is Extraneal approved in United States?

Yes. FDA authorised it on 20 December 2002; FDA authorised it on 20 December 2002.

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

BAXTER HLTHCARE holds the US marketing authorisation.