ANDA 40278, held by Fresenius Kabi USA. Fluorouracil.
As of Nov 14, 2026, ANDA 40278 (Fluorouracil), held by Fresenius Kabi USA, was first approved by FDA on Sep 30, 1998, with 5 approved supplements and 0 published complete response letters.
Fluorouracil is indicated for the treatment of patients with: Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 1998 | Original application | Approved |
| Fluorouracil2.5GM/50ML (50MG/ML) · injectable;injection | Fluorouracil | Rx |
| Fluorouracil5GM/100ML (50MG/ML) · injectable;injection | Fluorouracil | Rx |
| Feb 5, 2026 | Supplement 29Labeling · Standard review | Approved | |
| Mar 21, 2024 | Supplement 27Labeling · Standard review | Approved | |
| Jan 6, 2017 | Supplement 16Labeling · Standard review | Approved | None posted |
| Dec 5, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Jul 6, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Sep 30, 1998 | 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
