SAMSUNG BIOEPIS CO LTD Application 761100

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONTRUZANT	TRASTUZUMAB-DTTB	INJECTABLE;INJECTION	150MG	No	No
002	ONTRUZANT	TRASTUZUMAB-DTTB	POWDER;IV (INFUSION)	420MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-5033	Ontruzant	trastuzumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-5033	Ontruzant	trastuzumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-5034	Ontruzant	Ontruzant	Merck Sharp & Dohme Corp.	BLA	Current
0006-5034	Ontruzant	Ontruzant	Merck Sharp & Dohme Corp.	BLA	Current
78206-147	Ontruzant	trastuzumab	Organon LLC	BLA	Current
78206-148	Ontruzant	Ontruzant	Organon LLC	BLA	Current