Fluorouracil

NDA 12209, held by Spectrum Pharms. Fluorouracil.

As of Nov 13, 2026, NDA 12209 (Fluorouracil), held by Spectrum Pharms, was first approved by FDA on Apr 25, 1962, with 28 approved supplements and 0 published complete response letters.

First approved: Apr 25, 1962
Review: Priority
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Jul 29, 2016	Supplement 40Efficacy (new indication or use)	Approved	Letter Label
Apr 25, 1962	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Fluorouracil500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Fluorouracil	DiscontinuedReference drug
Fluorouracil2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Fluorouracil	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 29, 2016	Supplement 40Efficacy (new indication or use)	Approved	Letter Label
Jul 31, 2000	Supplement 39Manufacturing · Priority review	Approved	None posted
Jan 20, 1999	Supplement 38Manufacturing · Priority review	Approved	Review
Sep 15, 1997	Supplement 36Manufacturing · Priority review	Approved	None posted
May 5, 1995	Supplement 35Manufacturing · Priority review	Approved	None posted
May 12, 1994	Supplement 33Labeling · Standard review	Approved	None posted
Oct 18, 1991	Supplement 32Manufacturing · Priority review	Approved	None posted
May 20, 1991	Supplement 31Labeling	Approved	None posted
Mar 20, 1989	Supplement 30Manufacturing · Priority review	Approved	None posted
Oct 3, 1988	Supplement 29Labeling	Approved	None posted
May 19, 1988	Supplement 28Manufacturing · Priority review	Approved	None posted
Nov 26, 1986	Supplement 26Labeling	Approved	None posted
Nov 26, 1986	Supplement 20Labeling	Approved	None posted
Oct 21, 1986	Supplement 27Manufacturing · Priority review	Approved	None posted
Jul 1, 1986	Supplement 23Labeling	Approved	None posted
Jun 26, 1985	Supplement 25Manufacturing · Priority review	Approved	None posted
Jul 19, 1984	Supplement 21Labeling	Approved	None posted
May 12, 1983	Supplement 19Labeling	Approved	None posted
Jan 10, 1983	Supplement 15Manufacturing · Priority review	Approved	None posted
Mar 24, 1982	Supplement 18Labeling	Approved	None posted
Apr 4, 1980	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 8, 1979	Supplement 16Manufacturing · Priority review	Approved	None posted
Sep 29, 1978	Supplement 14Labeling	Approved	None posted
May 3, 1977	Supplement 13Labeling	Approved	None posted
Sep 29, 1976	Supplement 12Manufacturing · Priority review	Approved	None posted
Sep 27, 1976	Supplement 11Manufacturing · Priority review	Approved	None posted
Sep 27, 1976	Supplement 10Manufacturing · Priority review	Approved	None posted
Jul 22, 1975	Supplement 9Manufacturing · Priority review	Approved	None posted
Apr 25, 1962	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12209
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