FRESENIUS KABI USA Application 040263

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	No	Yes
002	METHOTREXATE SODIUM	METHOTREXATE SODIUM	INJECTABLE;INJECTION	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-123	Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-123	Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	ANDA	Current
63323-123	Methotrexate	METHOTREXATE SODIUM	Fresenius Kabi USA, LLC	ANDA	Current