Treats stage III colon cancer. ANDA 207385, held by Gland. Oxaliplatin.
As of Nov 14, 2026, ANDA 207385 (Oxaliplatin), held by Gland, was first approved by FDA on May 23, 2017, with 0 approved supplements and 0 published complete response letters.
Oxaliplatin for injection USP, used in combination with infusional 5-fluorouracil/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 |
|---|---|---|---|
| May 23, 2017 | Original application | Approved | None posted |
| Oxaliplatin50MG/VIAL · injectable;intravenous | Oxaliplatin | Rx |
| Oxaliplatin100MG/VIAL · 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
