Application 207960

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	20MG	Yes	No
002	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	30MG	Yes	No
003	QUILLICHEW ER	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL	40MG	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24478-074	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-074	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-075	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-075	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-076	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-076	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc	NDA	Current
24478-120	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc.	NDA	Current
24478-130	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc.	NDA	Current
24478-140	QuilliChew ER	methylphenidate hydrochloride	NextWave Pharmaceuticals, Inc.	NDA	Current