FDA — authorised 16 October 2014
- Application: NDA020896
- Marketing authorisation holder: CHEPLAPHARM
- Indication: Labeling
- Status: approved
🇺🇸 Xeloda in United States
FDA authorised Xeloda on 16 October 2014
Marketing authorisations
FDA — authorised 17 December 2019
- Application: ANDA091649
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
FDA — authorised 23 October 2023
- Application: ANDA217237
- Marketing authorisation holder: TEYRO LABS
- Status: approved
FDA — authorised 5 March 2024
- Application: ANDA210203
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
FDA — authorised 27 January 2026
- Application: ANDA207652
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
ALKEM LABS LTD received marketing authorisation from the FDA for Xeloda on 2026-01-27. The application number for this approval is ANDA207652. Xeloda is approved for its labelled indications.
Xeloda in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Xeloda approved in United States?
Yes. FDA authorised it on 16 October 2014; FDA authorised it on 17 December 2019; FDA authorised it on 23 October 2023.
Who is the marketing authorisation holder for Xeloda in United States?
CHEPLAPHARM holds the US marketing authorisation.