ANDA 78819, held by Fresenius Kabi USA. Oxaliplatin.
As of Nov 14, 2026, ANDA 78819 (Oxaliplatin), held by Fresenius Kabi USA, was first approved by FDA on Jun 2, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 2, 2010 | 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
