Application 213798

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 2MG BASE	No	No
002	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 4MG BASE	No	No
003	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 6MG BASE	No	No
004	TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 8MG BASE	No	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72888-001	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-001	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-002	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-002	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-003	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current
72888-003	tizanidine hydrochloride	tizanidine hydrochloride	Advagen Pharma Limited	ANDA	Current