🇺🇸 Alfenta in United States

FDA authorised Alfenta on 29 December 1986

Marketing authorisations

FDA — authorised 29 December 1986

  • Application: NDA019353
  • Marketing authorisation holder: RISING
  • Local brand name: ALFENTA
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 28 October 1999

  • Application: ANDA075221
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: ALFENTANIL
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Status: approved

Alfenta in other countries

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

Other Pain approved in United States

Frequently asked questions

Is Alfenta approved in United States?

Yes. FDA authorised it on 29 December 1986; FDA authorised it on 28 October 1999; FDA has authorised it.

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

RISING holds the US marketing authorisation.