FDA — authorised 8 August 2000
- Application: NDA020929
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: PULMICORT RESPULES
- Indication: SUSPENSION — INHALATION
- Status: approved
🇺🇸 Budesonide respules in United States
FDA authorised Budesonide respules on 8 August 2000
Marketing authorisations
FDA
- Status: approved
Budesonide respules in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Budesonide respules approved in United States?
Yes. FDA authorised it on 8 August 2000; FDA has authorised it.
Who is the marketing authorisation holder for Budesonide respules in United States?
ASTRAZENECA holds the US marketing authorisation.