FDA — authorised 20 May 2011
- Application: NDA021636
- Marketing authorisation holder: SALIX
- Indication: Labeling
- Status: approved
🇺🇸 Prilosec in United States
FDA authorised Prilosec on 20 May 2011
Marketing authorisations
FDA — authorised 7 November 2016
- Application: ANDA204923
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 31 May 2018
- Application: ANDA075410
- Marketing authorisation holder: LANNETT CO INC
- Indication: Labeling
- Status: approved
FDA — authorised 30 April 2020
- Application: ANDA212587
- Marketing authorisation holder: ANDA REPOSITORY
- Status: approved
FDA — authorised 8 November 2024
- Application: ANDA206877
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
Aurobindo Pharma has been granted marketing authorisation by the FDA for Prilosec (lansoprazole) on 08 November 2024. The approval was granted under application number ANDA206877, which was reviewed through the standard expedited pathway. Prilosec is indicated for use in labelling, but the specific local brand name is not reported.
Prilosec in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Prilosec approved in United States?
Yes. FDA authorised it on 20 May 2011; FDA authorised it on 7 November 2016; FDA authorised it on 31 May 2018.
Who is the marketing authorisation holder for Prilosec in United States?
SALIX holds the US marketing authorisation.