🇺🇸 Remifentanil R8 in United States

FDA authorised Remifentanil R8 on 12 July 1996

Marketing authorisations

FDA — authorised 12 July 1996

  • Application: NDA020630
  • Marketing authorisation holder: MYLAN INSTITUTIONAL
  • Local brand name: ULTIVA
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

FDA

  • Status: approved

Remifentanil R8 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 Remifentanil R8 approved in United States?

Yes. FDA authorised it on 12 July 1996; FDA has authorised it.

Who is the marketing authorisation holder for Remifentanil R8 in United States?

MYLAN INSTITUTIONAL holds the US marketing authorisation.