FDA — authorised 9 April 2008
- Application: ANDA077756
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
🇺🇸 LEVALBUTEROL HYDROCHLORIDE in United States
FDA authorised LEVALBUTEROL HYDROCHLORIDE on 9 April 2008 · 597 US adverse-event reports
Marketing authorisations
FDA — authorised 20 March 2009
- Application: ANDA078309
- Marketing authorisation holder: MYLAN SPECIALITY LP
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 15 March 2013
- Application: ANDA077800
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 26 April 2013
- Application: ANDA090297
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 13 December 2013
- Application: ANDA078171
- Marketing authorisation holder: CIPLA
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 11 September 2014
- Application: ANDA200875
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 22 March 2016
- Application: ANDA203653
- Marketing authorisation holder: RITEDOSE CORP
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 30 December 2016
- Application: ANDA207625
- Marketing authorisation holder: LUOXIN AUROVITAS
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 31 January 2017
- Application: ANDA207628
- Marketing authorisation holder: LUOXIN AUROVITAS
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 5 November 2018
- Application: ANDA207820
- Marketing authorisation holder: SUN PHARM
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 21 October 2024
- Application: ANDA218770
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: LEVALBUTEROL HYDROCHLORIDE
- 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: 597
Most-reported reactions
- Dyspnoea — 91 reports (15.24%)
- Pneumonia — 80 reports (13.4%)
- Cough — 72 reports (12.06%)
- Nausea — 60 reports (10.05%)
- Fatigue — 53 reports (8.88%)
- Off Label Use — 53 reports (8.88%)
- Asthma — 52 reports (8.71%)
- Covid-19 — 46 reports (7.71%)
- Diarrhoea — 46 reports (7.71%)
- Product Dose Omission Issue — 44 reports (7.37%)
LEVALBUTEROL HYDROCHLORIDE 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 LEVALBUTEROL HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 9 April 2008; FDA authorised it on 20 March 2009; FDA authorised it on 15 March 2013.
Who is the marketing authorisation holder for LEVALBUTEROL HYDROCHLORIDE in United States?
IMPAX LABS INC holds the US marketing authorisation.