Fluorouracil

ANDA 89508, held by Bedford. Fluorouracil.

As of Nov 14, 2026, ANDA 89508 (Fluorouracil), held by Bedford, was first approved by FDA on Jan 26, 1988, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 26, 1988
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
Jan 26, 1988	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


Feb 16, 1989	Supplement 3Labeling	Approved	None posted
Jul 20, 1988	Supplement 2Manufacturing	Approved	None posted
Jul 18, 1988	Supplement 1Manufacturing	Approved	None posted
Jan 26, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89508
Drugs@FDA: Overview at FDA
Company: Bedford Laboratories

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