FDA — authorised 24 September 1981
- Application: NDA018148
- Marketing authorisation holder: IVAX RES
- Local brand name: NASALIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
🇺🇸 Aerospan Hfa in United States
FDA authorised Aerospan Hfa on 24 September 1981
Marketing authorisations
FDA — authorised 24 September 1981
- Status: approved
FDA — authorised 27 January 2006
- Application: NDA021247
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: AEROSPAN HFA
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
FDA — authorised 3 August 2006
- Application: ANDA077704
- Marketing authorisation holder: RISING
- Local brand name: FLUNISOLIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 9 August 2007
- Application: ANDA077436
- Marketing authorisation holder: APOTEX
- Local brand name: FLUNISOLIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 16 June 2022
- Application: ANDA207802
- Marketing authorisation holder: RICONPHARMA LLC
- Local brand name: FLUNISOLIDE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 12 December 2024
- Application: ANDA074805
- Marketing authorisation holder: BAUSCH
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Aerospan Hfa, manufactured by BAUSCH, on 12 December 2024. The approval was granted under the standard expedited pathway for manufacturing (CMC) purposes. This approval allows BAUSCH to manufacture Aerospan Hfa in the United States.
Aerospan Hfa 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 Aerospan Hfa approved in United States?
Yes. FDA authorised it on 24 September 1981; FDA authorised it on 24 September 1981; FDA authorised it on 27 January 2006.
Who is the marketing authorisation holder for Aerospan Hfa in United States?
IVAX RES holds the US marketing authorisation.