FDA — authorised 11 December 2018
- Application: NDA208901
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: TOLSURA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Tolsura in United States
FDA authorised Tolsura on 11 December 2018
Marketing authorisation
Other Other approved in United States
Frequently asked questions
Is Tolsura approved in United States?
Yes. FDA authorised it on 11 December 2018.
Who is the marketing authorisation holder for Tolsura in United States?
MAYNE PHARMA holds the US marketing authorisation.