Fluorouracil

ANDA 202669, held by Eugia Pharma Speclts. Fluorouracil.

As of Nov 14, 2026, ANDA 202669 (Fluorouracil), held by Eugia Pharma Speclts, was first approved by FDA on Jul 17, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 17, 2012
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 17, 2012	Original application	Approved	None posted

Products

2 strengths and forms


Fluorouracil2.5GM/50ML (50MG/ML) · injectable;injection	Fluorouracil	Rx
Fluorouracil5GM/100ML (50MG/ML) · injectable;injection	Fluorouracil	Rx

All 4 submissions, including labeling and manufacturing supplements


Feb 5, 2026	Supplement 11Labeling · Standard review	Approved	Letter
Mar 21, 2024	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 14, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Jul 17, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202669
Drugs@FDA: Overview at FDA
Company: Eugia Pharma Specialities

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