FDA — authorised 29 March 2005
- Application: NDA021797
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: BARACLUDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Therapeutic entecavir in United States
FDA authorised Therapeutic entecavir on 29 March 2005
Marketing authorisations
FDA — authorised 29 March 2005
- Application: NDA021798
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: BARACLUDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
Therapeutic entecavir in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Therapeutic entecavir approved in United States?
Yes. FDA authorised it on 29 March 2005; FDA authorised it on 29 March 2005; FDA has authorised it.
Who is the marketing authorisation holder for Therapeutic entecavir in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.