FDA — authorised 22 October 2019
- Application: ANDA091650
- Marketing authorisation holder: DR REDDYS LABS LTD
- Indication: Labeling
- Status: approved
🇺🇸 Lipitor in United States
FDA authorised Lipitor on 22 October 2019
Marketing authorisations
FDA — authorised 5 January 2024
- Application: ANDA217081
- Marketing authorisation holder: MANKIND PHARMA
- Status: approved
FDA — authorised 22 January 2024
- Application: ANDA214513
- Marketing authorisation holder: LAURUS
- Status: approved
FDA — authorised 13 February 2024
- Application: ANDA217118
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 11 March 2025
- Application: ANDA205300
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
The FDA approved Lipitor for its labelled indication on 11 March 2025. TEVA PHARMS USA is the marketing authorisation holder. The approval was granted under the standard expedited pathway, with application number ANDA205300.
Lipitor 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 Lipitor approved in United States?
Yes. FDA authorised it on 22 October 2019; FDA authorised it on 5 January 2024; FDA authorised it on 22 January 2024.
Who is the marketing authorisation holder for Lipitor in United States?
DR REDDYS LABS LTD holds the US marketing authorisation.