Fluorouracil

ANDA 210124, held by Gland. Fluorouracil.

As of Nov 14, 2026, ANDA 210124 (Fluorouracil), held by Gland, was first approved by FDA on Dec 26, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 26, 2017
Review: Standard
Supplements approved: 2
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
Dec 26, 2017	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


Nov 12, 2025	Supplement 12Labeling · Standard review	Tentative approval	Letter Label
Mar 21, 2024	Supplement 9Labeling · Standard review	Approved	Label Letter
Sep 14, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Dec 26, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 210124
Drugs@FDA: Overview at FDA
Company: Gland Pharma

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