Treats Stage III colon cancer as a single agent. ANDA 204668, held by Sun Pharm. Capecitabine.
As of Nov 15, 2026, ANDA 204668 (Capecitabine), held by Sun Pharm, was first approved by FDA on Jun 21, 2019, with 2 approved supplements and 0 published complete response letters.
Capecitabine 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 |
|---|---|---|---|
| Jun 21, 2019 | Original application | Approved | None posted |
| Capecitabine150MG · tablet;oral | Capecitabine | Discontinued |
| Capecitabine500MG · tablet;oral | Capecitabine | Discontinued |
| Jun 17, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jun 17, 2025 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jun 21, 2019 | 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
