FDA — authorised 2 July 2002
- Application: ANDA075895
- Marketing authorisation holder: BAXTER HLTHCARE
- Status: supplemented
🇺🇸 SEVOFLURANE in United States
FDA authorised SEVOFLURANE on 2 July 2002
Marketing authorisations
FDA — authorised 11 December 2002
- Application: NDA020478
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
FDA — authorised 2 May 2007
- Application: ANDA077867
- Marketing authorisation holder: PIRAMAL CRITICAL
- Indication: Labeling
- Status: approved
FDA — authorised 19 November 2007
- Application: ANDA078650
- Marketing authorisation holder: HALOCARBON PRODS
- Status: approved
FDA — authorised 3 November 2015
- Application: ANDA203793
- Marketing authorisation holder: SHANGHAI HENGRUI
- Status: approved
FDA — authorised 18 August 2023
- Application: ANDA214382
- Marketing authorisation holder: SHANDONG
- Status: approved
SEVOFLURANE 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 SEVOFLURANE approved in United States?
Yes. FDA authorised it on 2 July 2002; FDA authorised it on 11 December 2002; FDA authorised it on 2 May 2007.
Who is the marketing authorisation holder for SEVOFLURANE in United States?
BAXTER HLTHCARE holds the US marketing authorisation.