FDA — authorised 2 March 2022
- Application: ANDA214736
- Marketing authorisation holder: RITEDOSE CORP
- Status: approved
🇺🇸 Arformoterol Tartrate Inhalation Solution in United States
FDA authorised Arformoterol Tartrate Inhalation Solution on 2 March 2022 · 2 US adverse-event reports
Marketing authorisations
FDA — authorised 3 February 2025
- Application: ANDA218380
- Marketing authorisation holder: AUCTA
- Status: approved
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.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 2
Most-reported reactions
- Bronchitis Acute — 1 report (50%)
- Condition Aggravated — 1 report (50%)
Other Respiratory / Pulmonology approved in United States
Frequently asked questions
Is Arformoterol Tartrate Inhalation Solution approved in United States?
Yes. FDA authorised it on 2 March 2022; FDA authorised it on 3 February 2025.
Who is the marketing authorisation holder for Arformoterol Tartrate Inhalation Solution in United States?
RITEDOSE CORP holds the US marketing authorisation.