FDA — authorised 22 June 2021
- Application: ANDA213132
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
🇺🇸 ARFORMOTEROL TARTRATE in United States
FDA authorised ARFORMOTEROL TARTRATE on 22 June 2021 · 204 US adverse-event reports
Marketing authorisations
FDA — authorised 22 June 2021
- Application: ANDA207306
- Marketing authorisation holder: CIPLA
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 22 June 2021
- Application: ANDA213762
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 9 November 2021
- Application: ANDA200293
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 2 March 2022
- Application: ANDA214736
- Marketing authorisation holder: RITEDOSE CORP
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 10 May 2022
- Application: ANDA214779
- Marketing authorisation holder: ALEMBIC
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 26 May 2022
- Application: ANDA215385
- Marketing authorisation holder: SUN PHARM
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 15 November 2022
- Application: ANDA216128
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 2 April 2024
- Application: ANDA214901
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 17 May 2024
- Application: ANDA216303
- Marketing authorisation holder: NEOCUBES PHARMA
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 3 June 2024
- Application: ANDA215032
- Marketing authorisation holder: DR REDDYS
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 18 November 2024
- Application: ANDA218156
- Marketing authorisation holder: LEXENPHARM
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 3 February 2025
- Application: ANDA218380
- Marketing authorisation holder: AUCTA
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 7 March 2025
- Application: ANDA218555
- Marketing authorisation holder: MICRO LABS
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 25 April 2025
- Application: ANDA218429
- Marketing authorisation holder: SABA ILAC SANAYI
- Local brand name: ARFORMOTEROL TARTRATE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA
- 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: 20 April 2025 – 20 April 2026
- Total reports: 204
Most-reported reactions
- Dyspnoea — 42 reports (20.59%)
- Fatigue — 32 reports (15.69%)
- Pneumonia — 22 reports (10.78%)
- Diarrhoea — 18 reports (8.82%)
- Drug Ineffective — 18 reports (8.82%)
- Chronic Obstructive Pulmonary Disease — 17 reports (8.33%)
- Cough — 16 reports (7.84%)
- Asthenia — 15 reports (7.35%)
- Nausea — 13 reports (6.37%)
- Bronchitis — 11 reports (5.39%)
ARFORMOTEROL TARTRATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ARFORMOTEROL TARTRATE approved in United States?
Yes. FDA authorised it on 22 June 2021; FDA authorised it on 22 June 2021; FDA authorised it on 22 June 2021.
Who is the marketing authorisation holder for ARFORMOTEROL TARTRATE in United States?
GLENMARK PHARMS LTD holds the US marketing authorisation.