Application 761201

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEMGLEE	INSULIN GLARGINE-YFGN	INJECTABLE;INJECTION	10ML(100UNITS/ML)	No	No
002	SEMGLEE	INSULIN GLARGINE-YFGN	INJECTABLE;INJECTION	3ML(100UNITS/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49502-250	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-250	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-250	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-250	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-251	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-251	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-251	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-251	SEMGLEE	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-393	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-393	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-393	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-394	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-394	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current
49502-394	Insulin Glargine	insulin glargine-yfgn	Mylan Specialty L.P.	BLA	Current