FDA — authorised 2 August 1990
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
🇺🇸 Cetanol in United States
FDA authorised Cetanol on 2 August 1990
Marketing authorisations
FDA — authorised 2 August 1990
- Application: NDA020044
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: EXOSURF NEONATAL
- Indication: FOR SUSPENSION — INTRATRACHEAL
- Status: approved
Cetanol 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 Cetanol approved in United States?
Yes. FDA authorised it on 2 August 1990; FDA authorised it on 2 August 1990.
Who is the marketing authorisation holder for Cetanol in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.