🇺🇸 Zofran in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Zofran (ondansetron) regulatory status in United States.

Marketing authorisation

FDA

Status: approved

Other Gastroenterology approved in United States

Frequently asked questions

Is Zofran approved in United States?

Yes. FDA has authorised it.

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

GSK (originally Glaxo) is the originator. The local marketing authorisation holder may differ — check the official source linked above.