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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 203122

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NDA 203122 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 sixteen 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 suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

Summary for 203122

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

Medical Subject Heading (MeSH) Categories for 203122

Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.5%
Approval Date:	Apr 20, 2015	TE:		RLD:	No

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