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FDA ANDA · ANDA209219

FLUOROURACIL

Sponsor: INGENUS PHARMS LLC

APPLICATION
ANDA209219
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-12
LATEST ACTION
2026-02-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FLUOROURACILDiscontinued
FLUOROURACIL 1GM/20ML (50MG/ML) · INJECTABLE · INJECTION
FLUOROURACILDiscontinued
FLUOROURACIL 500MG/10ML (50MG/ML) · INJECTABLE · INJECTION

Approval history

2026-02-05Labeling · Supplement 5 · standard — Letter ↗AP
2024-03-21Labeling · Supplement 2 · standard — Letter ↗AP
2019-12-12UNKNOWN · Original · standardAP
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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