FDA — authorised 1 November 2001
- Application: NDA021268
- Marketing authorisation holder: ABBVIE
- Local brand name: TEVETEN HCT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 EPROSARTAN MESYLATE in United States
FDA authorised EPROSARTAN MESYLATE on 1 November 2001
Marketing authorisations
FDA — authorised 16 November 2011
- Application: ANDA202012
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: EPROSARTAN MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
EPROSARTAN MESYLATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is EPROSARTAN MESYLATE approved in United States?
Yes. FDA authorised it on 1 November 2001; FDA authorised it on 16 November 2011; FDA has authorised it.
Who is the marketing authorisation holder for EPROSARTAN MESYLATE in United States?
ABBVIE holds the US marketing authorisation.