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FDA ANDA · ANDA040333

FLUOROURACIL

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA040333
TYPE
ANDA
ORIGINAL APPROVAL
2000-01-27
LATEST ACTION
2026-02-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FLUOROURACILDiscontinued
FLUOROURACIL 500MG/10ML (50MG/ML) · INJECTABLE · INJECTION

Approval history

2026-02-10Labeling · Supplement 34 · standardLetterAP
2024-03-21Labeling · Supplement 33 · standardLetterAP
2016-12-27Labeling · Supplement 30 · standardAP
2000-01-27OriginalLabelAP
VIEW ON DRUGS@FDA ↗

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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.

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