ANDA 203008, held by Am Regent. Floxuridine.
As of Nov 15, 2026, ANDA 203008 (Floxuridine), held by Am Regent, was first approved by FDA on Nov 22, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Floxuridine500MG/VIAL ยท injectable;injection | Floxuridine | 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
