FDA — authorised 11 March 2005
- Application: NDA021730
- Marketing authorisation holder: LUPIN
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Levalbuterol in United States
FDA authorised Levalbuterol on 11 March 2005
Marketing authorisations
FDA — authorised 26 April 2013
- Application: ANDA090297
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
FDA — authorised 13 December 2013
- Application: ANDA078171
- Marketing authorisation holder: CIPLA
- Status: supplemented
FDA — authorised 30 December 2016
- Application: ANDA207625
- Marketing authorisation holder: LUOXIN AUROVITAS
- Indication: Labeling
- Status: approved
FDA — authorised 31 January 2017
- Application: ANDA207628
- Marketing authorisation holder: LUOXIN AUROVITAS
- Status: approved
FDA — authorised 20 December 2019
- Application: ANDA207820
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
Levalbuterol 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 Levalbuterol approved in United States?
Yes. FDA authorised it on 11 March 2005; FDA authorised it on 26 April 2013; FDA authorised it on 13 December 2013.
Who is the marketing authorisation holder for Levalbuterol in United States?
LUPIN holds the US marketing authorisation.