FDA — authorised 17 March 1994
- Marketing authorisation holder: ORGANON USA INC
- Status: approved
🇺🇸 Zemuron in United States
FDA authorised Zemuron on 17 March 1994
Marketing authorisations
FDA — authorised 29 December 2008
- Application: ANDA078651
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 2 March 2023
- Application: ANDA216234
- Marketing authorisation holder: CAPLIN
- Status: approved
FDA — authorised 22 July 2024
- Application: ANDA217092
- Marketing authorisation holder: STERISCIENCE
- Status: approved
FDA — authorised 29 May 2025
- Application: ANDA219674
- Marketing authorisation holder: MANKIND PHARMA
- Status: approved
FDA — authorised 24 October 2025
- Application: NDA219108
- Marketing authorisation holder: B BRAUN MEDICAL
- Status: approved
Zemuron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Zemuron approved in United States?
Yes. FDA authorised it on 17 March 1994; FDA authorised it on 29 December 2008; FDA authorised it on 2 March 2023.
Who is the marketing authorisation holder for Zemuron in United States?
ORGANON USA INC holds the US marketing authorisation.