Application 018703

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZANTAC 150	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	ZANTAC 300	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
0173-0393	ZANTAC	ranitidine hydrochloride	GlaxoSmithKline LLC	NDA	Current