🇺🇸 Quetiapine Fumarate Sustained Release in United States

FDA authorised Quetiapine Fumarate Sustained Release on 17 May 2007

Marketing authorisations

FDA — authorised 17 May 2007

  • Application: NDA022047
  • Marketing authorisation holder: CHEPLAPHARM
  • Local brand name: SEROQUEL XR
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

Read official source →

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

Read official source →

Other Psychiatry approved in United States

Frequently asked questions

Is Quetiapine Fumarate Sustained Release approved in United States?

Yes. FDA authorised it on 17 May 2007; FDA authorised it on 15 November 2007.

Who is the marketing authorisation holder for Quetiapine Fumarate Sustained Release in United States?

CHEPLAPHARM holds the US marketing authorisation.