FDA — authorised 1 October 1999
- Application: NDA020746
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: RHINOCORT ALLERGY
- Indication: SPRAY, METERED — NASAL
- Status: approved
🇺🇸 Entocort in United States
FDA authorised Entocort on 1 October 1999
Marketing authorisations
FDA — authorised 12 May 2014
- Application: ANDA078949
- Marketing authorisation holder: APOTEX
- Local brand name: BUDESONIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 28 September 2017
- Application: ANDA209041
- Marketing authorisation holder: SCIECURE PHARMA INC
- Local brand name: BUDESONIDE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 16 November 2017
- Application: ANDA205710
- Marketing authorisation holder: CIPLA
- Local brand name: BUDESONIDE
- Indication: SUSPENSION — INHALATION
- Status: approved
FDA — authorised 15 March 2022
- Application: ANDA211699
- Marketing authorisation holder: MYLAN
- Local brand name: BREYNA
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 12 April 2023
- Application: ANDA215328
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: BUDESONIDE
- Indication: AEROSOL, FOAM — RECTAL
- Status: approved
FDA — authorised 28 April 2023
- Application: NDA216579
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: SYMBICORT AEROSPHERE
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Entocort approved in United States?
Yes. FDA authorised it on 1 October 1999; FDA authorised it on 12 May 2014; FDA authorised it on 28 September 2017.
Who is the marketing authorisation holder for Entocort in United States?
KENVUE BRANDS holds the US marketing authorisation.