FDA — authorised 2 November 2016
- Application: ANDA040481
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
🇺🇸 Lanoxin in United States
FDA authorised Lanoxin on 2 November 2016
Marketing authorisations
FDA — authorised 24 August 2018
- Application: NDA020405
- Marketing authorisation holder: ADVANZ PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 4 October 2019
- Application: ANDA213000
- Marketing authorisation holder: VISTAPHARM LLC
- Status: approved
FDA — authorised 7 October 2020
- Application: ANDA076363
- Marketing authorisation holder: SUN PHARM INDS INC
- Indication: Labeling
- Status: approved
FDA — authorised 8 February 2022
- Application: ANDA214982
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
Lanoxin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Lanoxin approved in United States?
Yes. FDA authorised it on 2 November 2016; FDA authorised it on 24 August 2018; FDA authorised it on 4 October 2019.
Who is the marketing authorisation holder for Lanoxin in United States?
SANDOZ holds the US marketing authorisation.