ANDA 78816, held by Mustafa Nevsat Iiac Sanayii A.S.. Oxaliplatin.
As of Nov 14, 2026, ANDA 78816 (Oxaliplatin), held by Mustafa Nevsat Iiac Sanayii A.S., was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2009 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxaliplatin5MG/ML · injectable; injection | Oxaliplatin | None (tentative approval) |
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
