FDA — authorised 16 February 2001
- Application: NDA050781
- Marketing authorisation holder: ORAPHARMA
- Status: supplemented
🇺🇸 Arestin in United States
FDA authorised Arestin on 16 February 2001
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Arestin approved in United States?
Yes. FDA authorised it on 16 February 2001; FDA has authorised it.
Who is the marketing authorisation holder for Arestin in United States?
ORAPHARMA holds the US marketing authorisation.