ANDA 40279, held by Fresenius Kabi USA. Fluorouracil.
As of Nov 14, 2026, ANDA 40279 (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: Adenocarcinoma of the Colon and Rectum Adenocarcinoma of the Breast Gastric Adenocarcinoma Pancreatic Adenocarcinoma Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum Adenocarcinoma of the Breast Gastric Adenocarcinoma Pancreatic Adenocarcinoma
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 1998 | Original application | Approved |
| Fluorouracil1GM/20ML (50MG/ML) · injectable;injection | Fluorouracil | Rx |
| Fluorouracil500MG/10ML (50MG/ML) · injectable;injection | Fluorouracil | Rx |
| Feb 5, 2026 | Supplement 32Labeling · Standard review | Approved | |
| Mar 21, 2024 | Supplement 30Labeling · Standard review | Approved | |
| Jan 6, 2017 | Supplement 19Labeling · 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
