FDA — authorised 12 July 2006
- Application: NDA021949
- Marketing authorisation holder: CHEPLAPHARM
- Local brand name: PULMICORT FLEXHALER
- Indication: POWDER, METERED — INHALATION
- Status: approved
FDA authorised Beclomethasone, Budesonide, Fluticasone on 12 July 2006
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 July 2006; FDA has authorised it.
CHEPLAPHARM holds the US marketing authorisation.