Fluorouracil

ANDA 203609, held by Sagent Pharms Inc. Fluorouracil.

As of Nov 14, 2026, ANDA 203609 (Fluorouracil), held by Sagent Pharms Inc, was first approved by FDA on Feb 17, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 17, 2016
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
Feb 17, 2016	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 15Labeling · Standard review	Approved	Letter Label
Mar 21, 2024	Supplement 14Labeling · Standard review	Approved	Label Letter
Nov 14, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Feb 17, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 203609
Drugs@FDA: Overview at FDA
Company: Sagent Pharmaceuticals

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