Fluorouracil

ANDA 40798, held by Accord Hlthcare. Fluorouracil.

As of Nov 14, 2026, ANDA 40798 (Fluorouracil), held by Accord Hlthcare, was first approved by FDA on Apr 26, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 26, 2007
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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

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
Apr 26, 2007	Original application	Approved	None posted

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Feb 5, 2026	Supplement 21Labeling · Standard review	Approved	Letter Label
Mar 21, 2024	Supplement 17Labeling · Standard review	Approved	Label Letter
Dec 27, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Apr 26, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 40798
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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