Fluorouracil

ANDA 203122, held by Extrovis. Fluorouracil.

As of Nov 15, 2026, ANDA 203122 (Fluorouracil), held by Extrovis, was first approved by FDA on Apr 20, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 20, 2015
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 20, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fluorouracil0.5% · cream;topical	Fluorouracil	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 12, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Apr 20, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203122
Drugs@FDA: Overview at FDA
Company: Extrovis

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