FDA — authorised 26 October 2012
- Application: NDA203585
- Marketing authorisation holder: TEVA PHARMS INTL
- Local brand name: SYNRIBO
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
🇺🇸 Synribo in United States
FDA authorised Synribo on 26 October 2012
Marketing authorisations
FDA
- Status: approved
Synribo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Synribo approved in United States?
Yes. FDA authorised it on 26 October 2012; FDA has authorised it.
Who is the marketing authorisation holder for Synribo in United States?
TEVA PHARMS INTL holds the US marketing authorisation.