FDA — authorised 29 March 2005
- Application: NDA021798
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: BARACLUDE
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Baraclude in United States
FDA authorised Baraclude on 29 March 2005
Marketing authorisations
FDA — authorised 29 March 2005
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: approved
FDA — authorised 29 March 2005
- Application: NDA021797
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: BARACLUDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 2014
- Application: ANDA202122
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 August 2015
- Application: ANDA205740
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2016
- Application: ANDA206294
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 December 2016
- Application: ANDA206872
- Marketing authorisation holder: CIPLA
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 2017
- Application: ANDA206672
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2017
- Application: ANDA206745
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 October 2017
- Application: ANDA208782
- Marketing authorisation holder: PRINSTON INC
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 March 2018
- Application: ANDA208721
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 March 2019
- Application: ANDA206217
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA206226
- Marketing authorisation holder: RISING
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 2019
- Application: ANDA212126
- Marketing authorisation holder: BRIGHTGENE
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2019
- Application: ANDA212201
- Marketing authorisation holder: YAOPHARMA CO LTD
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2020
- Application: ANDA211978
- Marketing authorisation holder: SUNSHINE
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 August 2020
- Application: ANDA212106
- Marketing authorisation holder: PHARMADAX
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 2021
- Application: ANDA208195
- Marketing authorisation holder: YUNG SHIN PHARM
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2024
- Application: ANDA216857
- Marketing authorisation holder: CONBA USA
- Local brand name: ENTECAVIR
- Indication: TABLET — ORAL
- Status: approved
Baraclude 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 Baraclude approved in United States?
Yes. FDA authorised it on 29 March 2005; FDA authorised it on 29 March 2005; FDA authorised it on 29 March 2005.
Who is the marketing authorisation holder for Baraclude in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.