Application 017443

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DANTRIUM	DANTROLENE SODIUM	CAPSULE;ORAL	25MG	Yes	No
002	DANTRIUM	DANTROLENE SODIUM	CAPSULE;ORAL	100MG	Yes	Yes
003	DANTRIUM	DANTROLENE SODIUM	CAPSULE;ORAL	50MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-124	Dantrium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-124	Dantrium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-125	Dantrium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-125	Dantrium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA	Current
42023-144	dantrolene sodium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
49884-362	dantrolene sodium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
49884-363	dantrolene sodium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
49884-364	dantrolene sodium	dantrolene sodium	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
63629-2168	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2168	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2168	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2169	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2169	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2169	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2170	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2170	dantrolene sodium	dantrolene sodium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current