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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 216494

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NDA 216494 describes FLUOROURACIL, which is a drug marketed by Accord Hlthcare, Dr Reddys Labs Sa, Encube, Extrovis, Taro, Abic, Abraxis Pharm, Alembic, Bedford, Ebewe Pharma, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland, Kindos, Marchar, Novast Labs, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, and Teva Pharms Usa, and is included in forty NDAs. It is available from seventeen suppliers. Additional details are available on the FLUOROURACIL profile page.

The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

Summary for 216494

Tradename:	FLUOROURACIL
Applicant:	Kindos
Ingredient:	fluorouracil
Patents:	0

Pharmacology for NDA: 216494

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 216494

Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

Suppliers and Packaging for NDA: 216494

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	216494	ANDA	Meitheal Pharmaceuticals Inc.	71288-170	71288-170-75	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-170-75) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2.5GM/50ML (50MG/ML)
Approval Date:	Sep 24, 2024	TE:	AP	RLD:	No

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