HIKMA PHARMS Application 204762

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DANTROLENE SODIUM	DANTROLENE SODIUM	INJECTABLE;INJECTION	20MG/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9297	Dantrolene	Dantrolene	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9297	Dantrolene	Dantrolene	West-Ward Pharmaceuticals Corp	ANDA	Current