🇺🇸 Aerosolized Calfactant in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Aerosolized Calfactant on 1 July 1998

Marketing authorisation

FDA — authorised 1 July 1998

Application: BLA020521
Marketing authorisation holder: ONY
Local brand name: INFASURF PRESERVATIVE FREE
Indication: SUSPENSION — INTRATRACHEAL
Status: approved

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Other Respiratory/Pulmonology approved in United States

Frequently asked questions

Is Aerosolized Calfactant approved in United States?

Yes. FDA authorised it on 1 July 1998.

Who is the marketing authorisation holder for Aerosolized Calfactant in United States?

ONY holds the US marketing authorisation.