Fluorouracil

ANDA 87792, held by Spectrum Pharms. Fluorouracil.

As of Nov 15, 2026, ANDA 87792 (Fluorouracil), held by Spectrum Pharms, was first approved by FDA on Oct 13, 1982, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 13, 1982
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
Oct 13, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fluorouracil50MG/ML · injectable;injection	Fluorouracil	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 6, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Aug 29, 1989	Supplement 5Manufacturing	Approved	None posted
May 28, 1986	Supplement 2Manufacturing	Approved	None posted
Oct 13, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87792
Drugs@FDA: Overview at FDA
Company: Spectrum 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