🇺🇸 Qvar Redihaler in United States

FDA authorised Qvar Redihaler on 3 August 2017

Marketing authorisations

FDA — authorised 3 August 2017

Application: NDA207921
Marketing authorisation holder: NORTON WATERFORD
Local brand name: QVAR REDIHALER
Indication: AEROSOL, METERED — INHALATION
Status: approved

The FDA approved Qvar Redihaler, a medication for the maintenance treatment of asthma, on 26 September 2025. The approval was granted to Norton Waterford, the marketing authorisation holder. Qvar Redihaler is a dry powder inhaler containing beclomethasone dipropionate, an inhaled corticosteroid.

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FDA — authorised 30 March 2018

Application: NDA202813
Marketing authorisation holder: TEVA BRANDED PHARM
Indication: Manufacturing (CMC)
Status: approved

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FDA — authorised 16 December 2025

Application: ANDA213811
Marketing authorisation holder: AMNEAL IRELAND LTD
Status: approved

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FDA

Marketing authorisation holder: AMNEAL IRELAND LTD
Status: approved

Qvar Redihaler 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 Qvar Redihaler approved in United States?

Yes. FDA authorised it on 3 August 2017; FDA authorised it on 30 March 2018; FDA authorised it on 16 December 2025.

Who is the marketing authorisation holder for Qvar Redihaler in United States?

NORTON WATERFORD holds the US marketing authorisation.