Treats Stage III colon cancer as a single agent. ANDA 210604, held by Eugia Pharma. Capecitabine.
As of Nov 15, 2026, ANDA 210604 (Capecitabine), held by Eugia Pharma, was first approved by FDA on Apr 17, 2018, with 1 approved supplement and 0 published complete response letters.
Capecitabine tablets are a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. Breast Cancer treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 17, 2018 | Original application | Approved | None posted |
| Capecitabine150MG · tablet;oral | Capecitabine | Rx |
| Capecitabine500MG · tablet;oral | Capecitabine | Rx |
| Oct 28, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 17, 2018 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
