Application 202670

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MITOMYCIN	MITOMYCIN	INJECTABLE;INJECTION	5MG/VIAL	No	No
002	MITOMYCIN	MITOMYCIN	INJECTABLE;INJECTION	20MG/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-518	Mitomycin	Mitomycin	Mylan Institutional LLC	ANDA	Current
67457-519	Mitomycin	Mitomycin	Mylan Institutional LLC	ANDA	Current
67457-995	Mitomycin	Mitomycin	Mylan Institutional LLC	ANDA	Current
67457-995	Mitomycin	Mitomycin	Mylan Institutional LLC	ANDA	Current
67457-996	Mitomycin	Mitomycin	Mylan Institutional LLC	ANDA	Current
67457-996	Mitomycin	Mitomycin	Mylan Institutional LLC	ANDA	Current
72819-152	Mitomycin	Mitomycin	Archis Pharma LLC	ANDA	Current