FDA — authorised 1 July 2016
- Application: NDA205525
- Marketing authorisation holder: WELLHOUSE PHARMA
- Status: supplemented
🇺🇸 Syndros in United States
FDA authorised Syndros on 1 July 2016
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Syndros approved in United States?
Yes. FDA authorised it on 1 July 2016; FDA has authorised it.
Who is the marketing authorisation holder for Syndros in United States?
WELLHOUSE PHARMA holds the US marketing authorisation.