FDA — authorised 20 November 2012
- Application: ANDA078103
- Marketing authorisation holder: LUPIN
- Indication: Labeling
- Status: approved
🇺🇸 Zocor in United States
FDA authorised Zocor on 20 November 2012
Marketing authorisations
FDA — authorised 2 February 2015
- Application: NDA021687
- Marketing authorisation holder: ORGANON
- Indication: Labeling
- Status: approved
FDA — authorised 26 September 2019
- Application: ANDA208831
- Marketing authorisation holder: AMNEAL PHARMS CO
- Indication: Labeling
- Status: approved
FDA — authorised 13 October 2022
- Application: ANDA078155
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 16 December 2022
- Application: ANDA209222
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
Zocor 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 Zocor approved in United States?
Yes. FDA authorised it on 20 November 2012; FDA authorised it on 2 February 2015; FDA authorised it on 26 September 2019.
Who is the marketing authorisation holder for Zocor in United States?
LUPIN holds the US marketing authorisation.