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FDA ANDA · ANDA203609

FLUOROURACIL

Sponsor: SAGENT PHARMS INC

APPLICATION
ANDA203609
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-17
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 15 · standard — Letter ↗AP
2024-03-21Labeling · Supplement 14 · standard — Letter ↗AP
2016-11-14Labeling · Supplement 2 · standardAP
2016-02-17UNKNOWN · 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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