Application 216117

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	18MG	Yes	No
002	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	27MG	Yes	No
003	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	36MG	Yes	No
004	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	45MG	Yes	No
005	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	54MG	Yes	No
006	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	63MG	Yes	No
007	RELEXXII	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	72MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-700	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	NDA	Current
13811-711	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	NDA	Current
68025-088	RELEXXII	methylphyenidate hydrochloride extended-release	Vertical Pharmaceuticals, LLC	NDA	Current
68025-089	RELEXXII	methylphyenidate hydrochloride extended-release	Vertical Pharmaceuticals, LLC	NDA	Current