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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077524

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NDA 077524 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 077524

Tradename:	FLUOROURACIL
Applicant:	Dr Reddys Labs Sa
Ingredient:	fluorouracil
Patents:	0

Pharmacology for NDA: 077524

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 077524

Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

Suppliers and Packaging for NDA: 077524

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOROURACIL	fluorouracil	CREAM;TOPICAL	077524	ANDA	Mayne Pharma Inc.	51862-362	51862-362-40	1 TUBE in 1 CARTON (51862-362-40) / 40 g in 1 TUBE
FLUOROURACIL	fluorouracil	CREAM;TOPICAL	077524	ANDA	Dr. Reddy's Labratories Inc.	75907-095	75907-095-40	1 TUBE in 1 CARTON (75907-095-40) / 40 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Apr 11, 2008	TE:	AB	RLD:	No

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