Treats stage III colon cancer. ANDA 217925, held by Hetero Labs Ltd Vi. Oxaliplatin.
As of Nov 14, 2026, ANDA 217925 (Oxaliplatin), held by Hetero Labs Ltd Vi, was first approved by FDA on Jan 27, 2025, with 0 approved supplements and 0 published complete response letters.
Oxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2025 | 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
