Treats stage III colon cancer. ANDA 217348, held by Meitheal. Oxaliplatin.
As of Nov 14, 2026, ANDA 217348 (Oxaliplatin), held by Meitheal, was first approved by FDA on Jan 11, 2024, with 0 approved supplements and 0 published complete response letters.
Oxaliplatin Injection, 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 11, 2024 | 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
