ANDA 216494, held by Kindos. Fluorouracil.
As of Nov 14, 2026, ANDA 216494 (Fluorouracil), held by Kindos, was first approved by FDA on Sep 24, 2024, with 1 approved supplement and 0 published complete response letters.
Fluorouracil Injection is indicated for the treatment of patients with: Fluorouracil Injection 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 1.1 Adenocarcinoma of the Colon and Rectum 1.2 Adenocarcinoma of the Breast 1.3 Gastric Adenocarcinoma 1.4 Pancreatic Adenocarcinoma
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorouracil2.5GM/50ML (50MG/ML) · injectable;injection | Fluorouracil | Rx |
| Feb 5, 2026 | Supplement 5Labeling · Standard review | Approved | |
| Sep 24, 2024 | Original application | Approved | None posted |
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
