FDA — authorised 6 June 2017
- Application: NDA208630
- Marketing authorisation holder: NXDC
- Status: supplemented
🇺🇸 Gleolan in United States
FDA authorised Gleolan on 6 June 2017
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Gleolan approved in United States?
Yes. FDA authorised it on 6 June 2017; FDA has authorised it.
Who is the marketing authorisation holder for Gleolan in United States?
NXDC holds the US marketing authorisation.