FDA — authorised 30 April 1998
- Application: NDA020896
- Marketing authorisation holder: CHEPLAPHARM
- Status: supplemented
🇺🇸 Xeloda in United States
FDA authorised Xeloda on 30 April 1998
Marketing authorisations
FDA
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is Xeloda approved in United States?
Yes. FDA authorised it on 30 April 1998; FDA has authorised it.
Who is the marketing authorisation holder for Xeloda in United States?
CHEPLAPHARM holds the US marketing authorisation.