Application 018303

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	TABLET;ORAL	25MG;50MG	Yes	No
002	LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	TABLET;ORAL	25MG;100MG	Yes	Yes
003	LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	TABLET;ORAL	50MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30698-460	Lopressor HCT	metoprolol tartrate and hydrochlorothiazide	Validus Pharmaceuticals LLC	NDA	Current