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FDA ANDA · ANDA202669

FLUOROURACIL

Sponsor: EUGIA PHARMA SPECLTS

APPLICATION
ANDA202669
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-17
LATEST ACTION
2026-02-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2026-02-05Labeling · Supplement 11 · standard — Letter ↗AP
2024-03-21Labeling · Supplement 9 · standard — Letter ↗AP
2016-12-14Labeling · Supplement 6 · standardAP
2012-07-17UNKNOWN · OriginalAP
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.

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