🇺🇸 Salbutamol (Ventolin®) in United States

FDA authorised Salbutamol (Ventolin®) on 1 August 1996

Marketing authorisations

FDA — authorised 1 August 1996

  • Application: ANDA074072
  • Marketing authorisation holder: PLIVA
  • Local brand name: ALBUTEROL
  • Indication: AEROSOL, METERED — INHALATION
  • Status: approved

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FDA — authorised 14 August 1996

  • Application: ANDA072273
  • Marketing authorisation holder: ARMSTRONG PHARMS
  • Local brand name: ALBUTEROL
  • Indication: AEROSOL, METERED — INHALATION
  • Status: approved

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FDA — authorised 19 August 1997

  • Application: ANDA073045
  • Marketing authorisation holder: GENPHARM
  • Local brand name: ALBUTEROL
  • Indication: AEROSOL, METERED — INHALATION
  • Status: approved

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Other Respiratory approved in United States

Frequently asked questions

Is Salbutamol (Ventolin®) approved in United States?

Yes. FDA authorised it on 1 August 1996; FDA authorised it on 14 August 1996; FDA authorised it on 19 August 1997.

Who is the marketing authorisation holder for Salbutamol (Ventolin®) in United States?

PLIVA holds the US marketing authorisation.