Details for New Drug Application (NDA): 016831

NDA 016831 describes EFUDEX, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the EFUDEX profile page.

The generic ingredient in EFUDEX 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 016831

Tradename:	EFUDEX
Applicant:	Bausch
Ingredient:	fluorouracil
Patents:	0

Pharmacology for NDA: 016831

Mechanism of Action

Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 016831

Antimetabolites

Antimetabolites, Antineoplastic

Immunosuppressive Agents

Suppliers and Packaging for NDA: 016831

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EFUDEX	fluorouracil	CREAM;TOPICAL	016831	NDA	Bausch Health US, LLC	0187-3204	0187-3204-47	1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE
EFUDEX	fluorouracil	SOLUTION;TOPICAL	016831	NDA	Bausch Health US, LLC	0187-3204	0187-3204-47	1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	2%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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