FDA — authorised 30 April 1998
- Application: NDA020896
- Marketing authorisation holder: CHEPLAPHARM
- Local brand name: XELODA
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Capecitabine Oral Product on 30 April 1998
Yes. FDA authorised it on 30 April 1998.
CHEPLAPHARM holds the US marketing authorisation.