FDA — authorised 26 April 2017
- Application: ANDA200909
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: EZETIMIBE AND SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ezetimibe and Simvastatin in United States
FDA authorised Ezetimibe and Simvastatin on 26 April 2017
Marketing authorisations
FDA — authorised 26 April 2017
- Application: ANDA201890
- Marketing authorisation holder: ANI PHARMS
- Local brand name: EZETIMIBE AND SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2017
- Application: ANDA202968
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: EZETIMIBE AND SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2017
- Application: ANDA208831
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: EZETIMIBE AND SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2017
- Application: ANDA209222
- Marketing authorisation holder: ALKEM LABS LTD
- Status: supplemented
FDA — authorised 27 June 2019
- Application: ANDA208699
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: EZETIMIBE AND SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 2020
- Application: ANDA200082
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: EZETIMIBE AND SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 2024
- Application: ANDA211663
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: EZETIMIBE AND SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2025
- Application: ANDA209461
- Marketing authorisation holder: TORRENT
- Local brand name: EZETIMIBE AND SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
Other Cardiovascular approved in United States
Frequently asked questions
Is Ezetimibe and Simvastatin approved in United States?
Yes. FDA authorised it on 26 April 2017; FDA authorised it on 26 April 2017; FDA authorised it on 26 April 2017.
Who is the marketing authorisation holder for Ezetimibe and Simvastatin in United States?
DR REDDYS LABS SA holds the US marketing authorisation.