Treats Stage III colon cancer as a single agent. ANDA 217237, held by Teyro Labs. Capecitabine.
As of Nov 15, 2026, ANDA 217237 (Capecitabine), held by Teyro Labs, was first approved by FDA on Oct 23, 2023, with 0 approved supplements and 0 published complete response letters.
Capecitabine tablets is 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 |
|---|---|---|---|
| Oct 23, 2023 | Original application | Approved | None posted |
| Capecitabine150MG · tablet;oral | Capecitabine | Rx |
| Capecitabine500MG · tablet;oral | Capecitabine | Rx |
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
