🇺🇸 albuterol inhalation aerosol in United States

FDA authorised albuterol inhalation aerosol on 15 August 1996 · 12 US adverse-event reports

Marketing authorisation

FDA — authorised 15 August 1996

  • Application: NDA020503
  • Marketing authorisation holder: KINDEVA
  • Local brand name: PROVENTIL-HFA
  • Indication: AEROSOL, METERED — INHALATION
  • Status: approved

Read official source →

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 2 reports (16.67%)
  2. Pharmaceutical Product Complaint — 2 reports (16.67%)
  3. Alopecia — 1 report (8.33%)
  4. Angioedema — 1 report (8.33%)
  5. Device Defective — 1 report (8.33%)
  6. Dizziness — 1 report (8.33%)
  7. Hair Colour Changes — 1 report (8.33%)
  8. Hair Disorder — 1 report (8.33%)
  9. Hair Texture Abnormal — 1 report (8.33%)
  10. Madarosis — 1 report (8.33%)

Source database →

Other Respiratory approved in United States

Frequently asked questions

Is albuterol inhalation aerosol approved in United States?

Yes. FDA authorised it on 15 August 1996.

Who is the marketing authorisation holder for albuterol inhalation aerosol in United States?

KINDEVA holds the US marketing authorisation.