Application 071130

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	2MG	No	No
002	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	5MG	No	No
003	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	10MG	No	No
004	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	0.5MG	No	No
005	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	1MG	No	No
006	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	20MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35573-440	HALOPERIDOL	HALOPERIDOL	Burel Pharmaceuticals, Inc.	ANDA	Current
35573-440	HALOPERIDOL	HALOPERIDOL	Burel Pharmaceuticals, LLC	ANDA	Current