FDA — authorised 10 November 1998
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
🇺🇸 Micardis in United States
FDA authorised Micardis on 10 November 1998
Marketing authorisations
FDA — authorised 25 November 2015
- Application: ANDA078710
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
FDA — authorised 4 November 2019
- Application: ANDA204164
- Marketing authorisation holder: JUBILANT GENERICS
- Indication: Labeling
- Status: approved
FDA — authorised 6 November 2019
- Application: ANDA203010
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
FDA — authorised 26 April 2023
- Application: ANDA091351
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
FDA — authorised 9 June 2023
- Application: ANDA206511
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
Micardis 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 Micardis approved in United States?
Yes. FDA authorised it on 10 November 1998; FDA authorised it on 25 November 2015; FDA authorised it on 4 November 2019.
Who is the marketing authorisation holder for Micardis in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.