FDA — authorised 1 May 1981
- Application: NDA017559
- Marketing authorisation holder: SCHERING
- Local brand name: PROVENTIL
- Indication: AEROSOL, METERED — INHALATION
- Status: approved
🇺🇸 ProAir in United States
FDA authorised ProAir on 1 May 1981
Marketing authorisations
FDA — authorised 7 May 1982
- Application: NDA017853
- Marketing authorisation holder: SCHERING
- Local brand name: PROVENTIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 January 1983
- Application: NDA018062
- Marketing authorisation holder: SCHERING
- Local brand name: PROVENTIL
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 29 March 2007
- Application: ANDA075664
- Marketing authorisation holder: NEPHRON
- Indication: Labeling
- Status: approved
FDA — authorised 29 March 2007
- Application: ANDA076355
- Marketing authorisation holder: NEPHRON
- Indication: Labeling
- Status: approved
FDA — authorised 6 September 2019
- Application: ANDA212197
- Marketing authorisation holder: QUAGEN
- Status: approved
FDA — authorised 29 September 2020
- Application: ANDA203760
- Marketing authorisation holder: PADAGIS US
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 December 2021
- Application: ANDA214531
- Marketing authorisation holder: RITEDOSE CORP
- Status: approved
ProAir in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is ProAir approved in United States?
Yes. FDA authorised it on 1 May 1981; FDA authorised it on 7 May 1982; FDA authorised it on 19 January 1983.
Who is the marketing authorisation holder for ProAir in United States?
SCHERING holds the US marketing authorisation.