Fluorouracil

ANDA 40334, held by Teva Pharms USA. Fluorouracil.

As of Nov 14, 2026, ANDA 40334 (Fluorouracil), held by Teva Pharms USA, was first approved by FDA on Feb 25, 2000, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 25, 2000
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 25, 2000	Original application	Approved	Label Letter Review

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Feb 10, 2026	Supplement 34Labeling · Standard review	Approved	Letter Label
Mar 21, 2024	Supplement 33Labeling · Standard review	Approved	Label Letter
Dec 28, 2016	Supplement 30Labeling · Standard review	Approved	None posted
Feb 25, 2000	Original application	Approved	Label Letter Review

Identifiers

Application: ANDA 40334
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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