FDA — authorised 14 December 2012
- Application: NDA200677
- Marketing authorisation holder: RECORDATI RARE
- Status: supplemented
🇺🇸 Signifor in United States
FDA authorised Signifor on 14 December 2012
Marketing authorisations
FDA — authorised 15 December 2014
- Application: NDA203255
- Marketing authorisation holder: RECORDATI RARE
- Status: supplemented
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Signifor approved in United States?
Yes. FDA authorised it on 14 December 2012; FDA authorised it on 15 December 2014; FDA has authorised it.
Who is the marketing authorisation holder for Signifor in United States?
RECORDATI RARE holds the US marketing authorisation.