Fluorouracil

ANDA 209219, held by Ingenus Pharms LLC. Fluorouracil.

As of Nov 14, 2026, ANDA 209219 (Fluorouracil), held by Ingenus Pharms LLC, was first approved by FDA on Dec 12, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 12, 2019
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 12, 2019	Original application	Approved	None posted

Products

2 strengths and forms


Fluorouracil500MG/10ML (50MG/ML) · injectable;injection	Fluorouracil	Discontinued
Fluorouracil1GM/20ML (50MG/ML) · injectable;injection	Fluorouracil	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 5, 2026	Supplement 5Labeling · Standard review	Approved	Letter Label
Mar 21, 2024	Supplement 2Labeling · Standard review	Approved	Label Letter
Dec 12, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 209219
Drugs@FDA: Overview at FDA
Company: Ingenus 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