Application 065058

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFACLOR	CEFACLOR	TABLET, EXTENDED RELEASE;ORAL	EQ 375MG BASE	No	No
002	CEFACLOR	CEFACLOR	TABLET, EXTENDED RELEASE;ORAL	EQ 500MG BASE	No	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1087	Cefaclor	Cefaclor	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1087	Cefaclor	Cefaclor	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1087	Cefaclor	Cefaclor	Teva Pharmaceuticals USA, Inc.	ANDA	Current