FDA — authorised 2 December 2015
- Application: NDA021265
- Marketing authorisation holder: SANDOZ CANADA INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA authorised Infuvite Adult on 2 December 2015
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 2 December 2015.
SANDOZ CANADA INC holds the US marketing authorisation.