Application 213261

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	INJECTABLE;INTRAVENOUS	EQ 50MG BASE/VIAL	No	No
002	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	INJECTABLE;INTRAVENOUS	EQ 100MG BASE/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9361	Micafungin	Micafungin sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9362	Micafungin	Micafungin sodium	Hikma Pharmaceuticals USA Inc.	ANDA	Current