FDA — authorised 28 December 2012
- Application: NDA202155
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: ELIQUIS
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Eliquis in United States
FDA authorised Eliquis on 28 December 2012
Marketing authorisations
FDA — authorised 23 December 2019
- Application: ANDA210128
- Marketing authorisation holder: MYLAN
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2019
- Application: ANDA210013
- Marketing authorisation holder: MICRO LABS
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2020
- Application: ANDA210152
- Marketing authorisation holder: BIONPHARMA
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 2020
- Application: ANDA210180
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 September 2020
- Application: ANDA209898
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2021
- Application: ANDA209845
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2023
- Application: ANDA210185
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 May 2023
- Application: ANDA210026
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2023
- Application: ANDA210066
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 February 2024
- Application: ANDA210091
- Marketing authorisation holder: APOTEX
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 2024
- Application: ANDA210156
- Marketing authorisation holder: TORRENT
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2025
- Application: ANDA209810
- Marketing authorisation holder: IMPAX
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2025
- Application: ANDA210067
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2025
- Application: NDA220073
- Marketing authorisation holder: BRISTOL
- Local brand name: ELIQUIS SPRINKLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA210142
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA210053
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA210171
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA213903
- Marketing authorisation holder: ZHEJIANG YONGNING PHARMACEUTICAL CO LTD
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA210082
- Marketing authorisation holder: DR REDDYS LABS INC
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA218519
- Marketing authorisation holder: FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO.,
- Local brand name: APIXABAN
- Indication: TABLET
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA210108
- Marketing authorisation holder: UNICHEM LABS LTD
- Local brand name: APIXABAN
- Indication: TABLET — FILM COATED
- Status: approved
FDA
- Application: ANDA210133
- Marketing authorisation holder: PRINSTON PHARMA INC
- Local brand name: APIXABAN
- Indication: TABLET — ORAL
- Status: approved
Eliquis 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 Eliquis approved in United States?
Yes. FDA authorised it on 28 December 2012; FDA authorised it on 23 December 2019; FDA authorised it on 23 December 2019.
Who is the marketing authorisation holder for Eliquis in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.