FDA — authorised 14 May 2004
- Application: NDA021433
- Marketing authorisation holder: GLAXO GRP LTD
- Local brand name: FLOVENT HFA
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA authorised fluticasone propionate hydrofluoroalkane (HFA) on 14 May 2004
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 14 May 2004; FDA has authorised it.
GLAXO GRP LTD holds the US marketing authorisation.