ANDA 204378, held by Am Regent. Oxaliplatin.
As of Nov 14, 2026, ANDA 204378 (Oxaliplatin), held by Am Regent, was first approved by FDA on May 12, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2017 | Original application | Approved | None posted |
| Oxaliplatin50MG/10ML (5MG/ML) · injectable;intravenous | Oxaliplatin | Discontinued |
| Oxaliplatin100MG/20ML (5MG/ML) · 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
