FDA — authorised 26 September 2003
- Application: NDA020929
- Marketing authorisation holder: ASTRAZENECA
- Indication: Labeling
- Status: approved
🇺🇸 Pulmicort Respules in United States
FDA authorised Pulmicort Respules on 26 September 2003
Marketing authorisations
FDA — authorised 18 November 2008
- Application: ANDA077519
- Marketing authorisation holder: TEVA PHARMS
- Status: approved
FDA — authorised 31 March 2021
- Application: ANDA078404
- Marketing authorisation holder: IMPAX LABS INC
- Indication: Labeling
- Status: approved
FDA — authorised 16 November 2021
- Application: ANDA205710
- Marketing authorisation holder: CIPLA
- Indication: Labeling
- Status: approved
FDA — authorised 29 November 2023
- Application: ANDA216667
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
Pulmicort Respules in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Pulmicort Respules approved in United States?
Yes. FDA authorised it on 26 September 2003; FDA authorised it on 18 November 2008; FDA authorised it on 31 March 2021.
Who is the marketing authorisation holder for Pulmicort Respules in United States?
ASTRAZENECA holds the US marketing authorisation.