FDA — authorised 25 October 2002
- Application: ANDA075474
- Marketing authorisation holder: TP ANDA HOLDINGS
- Status: approved
🇺🇸 Zebeta in United States
FDA authorised Zebeta on 25 October 2002
Marketing authorisations
FDA — authorised 11 January 2017
- Application: ANDA204891
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 18 January 2024
- Application: ANDA217617
- Marketing authorisation holder: HARMAN FINOCHEM
- Status: approved
FDA — authorised 25 June 2024
- Application: ANDA075768
- Marketing authorisation holder: MYLAN
- Indication: Labeling
- Status: approved
Mylan was granted marketing authorization by the FDA for Zebeta on June 25, 2024. This approval was granted under the standard expedited pathway. The approved indication for Zebeta is for labeling purposes, with the specific local brand name not reported.
FDA — authorised 16 April 2025
- Application: ANDA219044
- Marketing authorisation holder: UNIQUE PHARM
- Status: approved
Zebeta 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 Zebeta approved in United States?
Yes. FDA authorised it on 25 October 2002; FDA authorised it on 11 January 2017; FDA authorised it on 18 January 2024.
Who is the marketing authorisation holder for Zebeta in United States?
TP ANDA HOLDINGS holds the US marketing authorisation.