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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 203608

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NDA 203608 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 203608

Tradename:	FLUOROURACIL
Applicant:	Sagent Pharms Inc
Ingredient:	fluorouracil
Patents:	0

Medical Subject Heading (MeSH) Categories for 203608

Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/10ML (50MG/ML)
Approval Date:	May 11, 2017	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/20ML (50MG/ML)
Approval Date:	May 11, 2017	TE:	AP	RLD:	No

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