FDA — authorised 11 April 2000
- Application: NDA021103
- Marketing authorisation holder: NOVO NORDISK
- Local brand name: ACTIVELLA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Activella® in United States
FDA authorised Activella® on 11 April 2000
Marketing authorisations
FDA — authorised 29 December 2006
- Application: NDA022001
- Marketing authorisation holder: NOVO NORDISK INC
- Local brand name: ACTIVELLA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Activella® in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Activella® approved in United States?
Yes. FDA authorised it on 11 April 2000; FDA authorised it on 29 December 2006; FDA has authorised it.
Who is the marketing authorisation holder for Activella® in United States?
NOVO NORDISK holds the US marketing authorisation.