ANDA 40291, held by Fresenius Kabi USA. Fluorouracil.
As of Nov 14, 2026, ANDA 40291 (Fluorouracil), held by Fresenius Kabi USA, was first approved by FDA on Mar 24, 1999, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorouracil50MG/ML ยท injectable;injection | Fluorouracil | Discontinued |
| Nov 4, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Mar 24, 1999 | Original application | Approved |
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
