Application 211964

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QELBREE	VILOXAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	Yes	No
002	QELBREE	VILOXAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	150MG	Yes	No
003	QELBREE	VILOXAZINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-131	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-132	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current
17772-133	QELBREE	viloxazine hydrochloride	Supernus Pharmaceuticals, Inc	NDA	Current