Application 016831

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EFUDEX	FLUOROURACIL	SOLUTION;TOPICAL	2%	Yes	Yes
002	EFUDEX	FLUOROURACIL	SOLUTION;TOPICAL	5%	Yes	Yes
003	EFUDEX	FLUOROURACIL	CREAM;TOPICAL	5%	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-3204	Efudex	Fluorouracil	Bausch Health US LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US, LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US, LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US, LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US, LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health US LLC	NDA	Current
0187-3204	Efudex	Fluorouracil	Bausch Health Americas, Inc.	NDA	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA	Current
0378-4791	Fluorouracil	Fluorouracil	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
43547-258	Fluorouracil	Fluorouracil	Solco Healthcare US LLC	NDA	Current
43547-259	Fluorouracil	Fluorouracil	Solco Healthcare US LLC	NDA	Current