Application 213145

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	TABLET;ORAL	400MG	No	No
002	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	TABLET;ORAL	800MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70748-172	Sevelamer hydrochloride	Sevelamer hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
70748-173	Sevelamer hydrochloride	Sevelamer hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current