ANDA 40379, held by Fresenius Kabi USA. Fluorouracil.
As of Nov 14, 2026, ANDA 40379 (Fluorouracil), held by Fresenius Kabi USA, was first approved by FDA on Nov 15, 2000, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorouracil50MG/ML ยท injectable;injection | Fluorouracil | 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
