HIKMA Application 204988

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RUFINAMIDE	RUFINAMIDE	TABLET;ORAL	200MG	No	No
002	RUFINAMIDE	RUFINAMIDE	TABLET;ORAL	400MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0425	Rufinamide	Rufinamide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0425	Rufinamide	Rufinamide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0426	Rufinamide	Rufinamide	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0426	Rufinamide	Rufinamide	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
40431	ORIG	2016-06-01
32608	ORIG	2016-05-18