ANDA 78810, held by Fresenius Kabi Oncol. Oxaliplatin.
As of Nov 14, 2026, ANDA 78810 (Oxaliplatin), held by Fresenius Kabi Oncol, was first approved by FDA on Aug 7, 2009, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2009 | Original application | Approved |
| Oxaliplatin50MG/VIAL · injectable;intravenous | Oxaliplatin | Discontinued |
| Oxaliplatin100MG/VIAL · injectable;intravenous | Oxaliplatin | Discontinued |
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
