FDA — authorised 28 June 2017
- Application: ANDA202674
- Marketing authorisation holder: UNICHEM
- Indication: Labeling
- Status: approved
🇺🇸 Seroquel in United States
FDA authorised Seroquel on 28 June 2017
Marketing authorisations
FDA — authorised 30 June 2017
- Application: ANDA203390
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
FDA — authorised 6 December 2019
- Application: ANDA203359
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 20 December 2019
- Application: ANDA207655
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 19 April 2023
- Application: ANDA208781
- Marketing authorisation holder: PRINSTON INC
- Indication: Labeling
- Status: approved
Seroquel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Seroquel approved in United States?
Yes. FDA authorised it on 28 June 2017; FDA authorised it on 30 June 2017; FDA authorised it on 6 December 2019.
Who is the marketing authorisation holder for Seroquel in United States?
UNICHEM holds the US marketing authorisation.