FDA — authorised 3 November 2020
- Application: ANDA203825
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
🇺🇸 Bystolic in United States
FDA authorised Bystolic on 3 November 2020
Marketing authorisations
FDA — authorised 19 November 2021
- Application: ANDA203828
- Marketing authorisation holder: INDCHEMIE HEALTH
- Indication: Labeling
- Status: approved
FDA — authorised 26 January 2022
- Application: ANDA203821
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 25 August 2023
- Application: ANDA213830
- Marketing authorisation holder: UNICHEM
- Indication: Labeling
- Status: approved
FDA — authorised 28 January 2025
- Application: ANDA212661
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
Bystolic in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Bystolic approved in United States?
Yes. FDA authorised it on 3 November 2020; FDA authorised it on 19 November 2021; FDA authorised it on 26 January 2022.
Who is the marketing authorisation holder for Bystolic in United States?
HETERO LABS LTD III holds the US marketing authorisation.