Treats stage III colon cancer. ANDA 219765, held by Shandong. Oxaliplatin.
As of Nov 14, 2026, ANDA 219765 (Oxaliplatin), held by Shandong, was first approved by FDA on Jan 15, 2026, with 0 approved supplements and 0 published complete response letters.
Oxaliplatin injection USP, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 2026 | Original application | Approved | None posted |
| Oxaliplatin50MG/10ML (5MG/ML) · injectable;intravenous | Oxaliplatin | Rx |
| Oxaliplatin100MG/20ML (5MG/ML) · injectable;intravenous | Oxaliplatin | 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
