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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 216942

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NDA 216942 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 216942

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

Pharmacology for NDA: 216942

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 216942

Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents

Suppliers and Packaging for NDA: 216942

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOROURACIL	fluorouracil	CREAM;TOPICAL	216942	ANDA	Encube Ethicals, Inc.	21922-049	21922-049-17	1 TUBE in 1 CARTON (21922-049-17) / 40 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Feb 12, 2025	TE:	AB	RLD:	No

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