Application 090692

Related Records

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	Yes

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-582	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-582	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE	ANDA	Current
42291-583	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-583	Metformin Hydrochloride	Metformin Hydrochloride	AvKARE	ANDA	Current
63629-6939	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6939	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68180-336	Metformin Hydrochloride	Metformin Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-336	Metformin Hydrochloride	Metformin Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-336	Metformin Hydrochloride	Metformin Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-337	Metformin Hydrochloride	Metformin Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-337	Metformin Hydrochloride	Metformin Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-337	Metformin Hydrochloride	Metformin Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current