Application 091159

Type: ANDA
Sponsor: MOUNTAIN

Related Records

Company: MOUNTAIN

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1800	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1801	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Impax Generics	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1802	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
64720-238	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CorePharma, LLC	ANDA	Current
64720-239	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CorePharma, LLC	ANDA	Current