FDA ANDA · ANDA040278

FLUOROURACIL

Sponsor: FRESENIUS KABI USA

APPLICATION

ANDA040278

TYPE

ANDA

ORIGINAL APPROVAL

1998-09-30

LATEST ACTION

2026-02-05

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

FLUOROURACILPrescription

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

FLUOROURACILPrescription

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

2026-02-05Labeling · Supplement 29 · standard — Letter ↗AP

2024-03-21Labeling · Supplement 27 · standard — Letter ↗AP

2017-01-06Labeling · Supplement 16 · standardAP

2002-12-05Manufacturing (CMC) · Supplement 3AP

1999-07-06Manufacturing (CMC) · Supplement 1AP

1998-09-30Original — Label ↗AP

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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