ANDA 217295, held by Alembic. Fluorouracil.
As of Nov 14, 2026, ANDA 217295 (Fluorouracil), held by Alembic, was first approved by FDA on Mar 3, 2023, with 2 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 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 |
|---|---|---|---|
| Mar 3, 2023 | 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 | |
| Mar 21, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Mar 3, 2023 | 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
