Application 079108

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	No	No
004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1682	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1682	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-1682	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1682	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1683	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1683	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1683	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-1683	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1684	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1684	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-1684	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1684	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1685	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1685	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1685	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-1685	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1686	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1686	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1686	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-1686	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9918	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9918	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9918	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-9918	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9918	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9918	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9919	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9919	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9919	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9919	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-9919	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9919	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9920	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9920	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9920	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-9920	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9920	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9920	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9921	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9921	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9921	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9921	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-9921	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9921	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9922	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9922	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9922	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9922	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Impax Generics	ANDA	Current
0115-9922	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-9922	Dexmethylphenidate hydrochloride	Dexmethylphenidate hydrochloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31411	ORIG	2013-12-05

Application 079108

Related Records#

Application Products#

NDC Listings For This Application#

Documents#