← FDA DRUG APPROVALS

FDA ANDA · ANDA040334

FLUOROURACIL

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA040334
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-25
LATEST ACTION
2026-02-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FLUOROURACILDiscontinued
FLUOROURACIL 5GM/100ML (50MG/ML) · INJECTABLE · INJECTION
FLUOROURACILDiscontinued
FLUOROURACIL 2.5GM/50ML (50MG/ML) · INJECTABLE · INJECTION

Approval history

2026-02-10Labeling · Supplement 34 · standard — Letter ↗AP
2024-03-21Labeling · Supplement 33 · standard — Letter ↗AP
2016-12-28Labeling · Supplement 30 · standardAP
2000-02-25Original — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →