FDA — authorised 14 October 1999
- Application: BLA020521
- Marketing authorisation holder: ONY
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Infasurf in United States
FDA authorised Infasurf on 14 October 1999
Marketing authorisation
Infasurf in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Infasurf approved in United States?
Yes. FDA authorised it on 14 October 1999.
Who is the marketing authorisation holder for Infasurf in United States?
ONY holds the US marketing authorisation.