Application 205105

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No
005	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	No	No
006	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1736	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1736	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1736	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Impax Generics	ANDA	Current
0115-1736	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1736	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1736	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1737	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1737	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1737	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1737	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1737	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1737	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Impax Generics	ANDA	Current
0115-1738	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1738	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Impax Generics	ANDA	Current
0115-1738	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1738	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1738	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1738	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1739	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Impax Generics	ANDA	Current
0115-1739	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1739	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1739	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1739	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1739	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1740	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1740	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1740	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1740	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1740	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1740	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Impax Generics	ANDA	Current
0115-1741	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1741	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Impax Generics	ANDA	Current
0115-1741	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1741	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1741	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1741	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
64720-401	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	CorePharma, LLC	ANDA	Current
64720-402	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	CorePharma, LLC	ANDA	Current
64720-403	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	CorePharma, LLC	ANDA	Current
64720-404	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	CorePharma, LLC	ANDA	Current
64720-405	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	CorePharma, LLC	ANDA	Current
64720-406	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	CorePharma, LLC	ANDA	Current

Application 205105

Related Records#

Application Products#

NDC Listings For This Application#