FDA — authorised 25 October 2002
- Application: NDA021445
- Marketing authorisation holder: ORGANON
- Local brand name: ZETIA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Zetia in United States
FDA authorised Zetia on 25 October 2002
Marketing authorisations
FDA — authorised 25 October 2002
- Marketing authorisation holder: MSD INTL GMBH
- Status: approved
FDA — authorised 26 October 2018
- Application: ANDA211550
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
FDA — authorised 16 December 2022
- Application: ANDA208803
- Marketing authorisation holder: AMNEAL PHARMS CO
- Indication: Labeling
- Status: approved
FDA — authorised 17 October 2023
- Application: ANDA209838
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 29 April 2024
- Application: ANDA211159
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA — authorised 10 July 2024
- Application: ANDA210859
- Marketing authorisation holder: HETERO LABS LTD III
- Indication: Labeling
- Status: approved
The FDA approved the application number ANDA210859 for Zetia, a drug product, on 2024-07-10. The marketing authorisation holder is HETERO LABS LTD III. The indication approved is for labeling, but the specific indication is not reported.
Zetia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Zetia approved in United States?
Yes. FDA authorised it on 25 October 2002; FDA authorised it on 25 October 2002; FDA authorised it on 26 October 2018.
Who is the marketing authorisation holder for Zetia in United States?
ORGANON holds the US marketing authorisation.