Application 213247

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
24979-146	metformin hydrochloride	metformin hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-146	metformin hydrochloride	metformin hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-153	metformin hydrochloride	metformin hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-153	metformin hydrochloride	metformin hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
71205-859	metformin hydrochloride	metformin hydrochloride	Proficient Rx LP	ANDA	Current
71205-860	metformin hydrochloride	metformin hydrochloride	Proficient Rx LP	ANDA	Current