FDA — authorised 23 July 2004
- Application: NDA021687
- Marketing authorisation holder: ORGANON
- Local brand name: VYTORIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Vytorin in United States
FDA authorised Vytorin on 23 July 2004
Marketing authorisations
FDA — authorised 26 June 2015
- Application: ANDA078560
- Marketing authorisation holder: GLENMARK PHARMS LTD
- 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: ANDA208332
- Marketing authorisation holder: APOTEX
- Local brand name: EZETIMIBE
- Indication: TABLET — ORAL
- Status: approved
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: ANDA200831
- Marketing authorisation holder: WATSON LABS INC
- 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 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
FDA
- Status: approved
Vytorin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Vytorin approved in United States?
Yes. FDA authorised it on 23 July 2004; FDA authorised it on 26 June 2015; FDA authorised it on 12 June 2017.
Who is the marketing authorisation holder for Vytorin in United States?
ORGANON holds the US marketing authorisation.