Application 213320

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG	No	No
003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	1GM	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66064-1040	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1040	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1041	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1041	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1042	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1042	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current