Details for New Drug Application (NDA): 214845

NDA 214845 describes FLUOROURACIL, which is a drug marketed by Accord Hlthcare, Dr Reddys Labs Sa, Rising, Taro, Abic, Abraxis Pharm, Alembic, Bedford, Ebewe Pharma, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland Pharma Ltd, Kindos, Marchar, Novast Labs, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, and Encube, and is included in thirty-eight 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. Nineteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

Summary for 214845

Tradename:	FLUOROURACIL
Applicant:	Accord Hlthcare
Ingredient:	fluorouracil
Patents:	0

Pharmacology for NDA: 214845

Mechanism of Action

Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 214845

Antimetabolites

Antimetabolites, Antineoplastic

Immunosuppressive Agents

Suppliers and Packaging for NDA: 214845

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOROURACIL	fluorouracil	CREAM;TOPICAL	214845	ANDA	Accord Healthcare Inc.	16729-542	16729-542-35	1 TUBE in 1 CARTON (16729-542-35) / 40 g in 1 TUBE
FLUOROURACIL	fluorouracil	CREAM;TOPICAL	214845	ANDA	NuCare Pharmaceuticals,Inc.	68071-2961	68071-2961-4	1 TUBE in 1 CARTON (68071-2961-4) / 40 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Oct 7, 2021	TE:	AB	RLD:	No

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