FDA — authorised 17 May 2007
- Application: NDA022047
- Marketing authorisation holder: CHEPLAPHARM
- Local brand name: SEROQUEL XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Seroquel XR adjunctive in United States
FDA authorised Seroquel XR adjunctive on 17 May 2007
Marketing authorisations
FDA — authorised 15 November 2007
- Application: NDA022172
- Marketing authorisation holder: CHEPLAPHARM ARZNEIMITTEL GMBH
- Local brand name: SEROQUEL XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Seroquel XR adjunctive in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Seroquel XR adjunctive approved in United States?
Yes. FDA authorised it on 17 May 2007; FDA authorised it on 15 November 2007; FDA has authorised it.
Who is the marketing authorisation holder for Seroquel XR adjunctive in United States?
CHEPLAPHARM holds the US marketing authorisation.