Application 212969

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-520	METFORMIN HYDROCHLORIDE	metformin hydrochloride	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-520	METFORMIN HYDROCHLORIDE	metformin hydrochloride	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-521	METFORMIN HYDROCHLORIDE	metformin hydrochloride	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-521	METFORMIN HYDROCHLORIDE	metformin hydrochloride	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current