FDA — authorised 26 June 2015
- Application: ANDA078560
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 AD-221B in United States
FDA authorised AD-221B on 26 June 2015
Marketing authorisations
FDA — authorised 12 June 2017
- Application: ANDA204331
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2017
- Application: ANDA203931
- Marketing authorisation holder: SANDOZ
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2017
- Application: ANDA207311
- Marketing authorisation holder: OHM LABS INC
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2017
- Application: ANDA200831
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2017
- Application: ANDA208332
- Marketing authorisation holder: APOTEX
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2017
- Application: ANDA208803
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2017
- Application: ANDA078724
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 2017
- Application: ANDA209838
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA211550
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA201790
- Marketing authorisation holder: RISING
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 October 2020
- Application: ANDA210673
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2022
- Application: ANDA210859
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2022
- Application: ANDA215693
- Marketing authorisation holder: ORIENT PHARMA
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 2024
- Application: ANDA211159
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is AD-221B approved in United States?
Yes. FDA authorised it on 26 June 2015; FDA authorised it on 12 June 2017; FDA authorised it on 12 June 2017.
Who is the marketing authorisation holder for AD-221B in United States?
GLENMARK PHARMS LTD holds the US marketing authorisation.