FDA — authorised 28 August 2018
- Application: NDA205054
- Marketing authorisation holder: INVAGEN PHARMS
- Status: supplemented
🇺🇸 Lutrate in United States
FDA authorised Lutrate on 28 August 2018
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Lutrate approved in United States?
Yes. FDA authorised it on 28 August 2018; FDA has authorised it.
Who is the marketing authorisation holder for Lutrate in United States?
INVAGEN PHARMS holds the US marketing authorisation.