FDA — authorised 18 March 2010
- Application: NDA022562
- Marketing authorisation holder: RECORDATI RARE
- Status: supplemented
🇺🇸 Carbaglu in United States
FDA authorised Carbaglu on 18 March 2010
Marketing authorisations
FDA
- Status: approved
Carbaglu in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Carbaglu approved in United States?
Yes. FDA authorised it on 18 March 2010; FDA has authorised it.
Who is the marketing authorisation holder for Carbaglu in United States?
RECORDATI RARE holds the US marketing authorisation.