Treats Stage III colon cancer as a single agent. ANDA 207652, held by Alkem Labs Ltd. Capecitabine.
As of Nov 15, 2026, ANDA 207652 (Xoridrono), held by Alkem Labs Ltd, was first approved by FDA on Nov 27, 2017, with 2 approved supplements 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 |
|---|---|---|---|
| Nov 27, 2017 | Original application | Approved | None posted |
| Xoridrono150MG · tablet;oral | Capecitabine | Rx |
| Xoridrono500MG · tablet;oral | Capecitabine | Rx |
| Jan 27, 2026 | Supplement 13Labeling · Standard review | Approved | None posted |
| Oct 9, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 27, 2017 | 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
