Application 210605

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEMGLEE	INSULIN GLARGINE	INJECTABLE;INJECTION	100 UNITS/ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49502-195	SEMGLEE	insulin glargine	Mylan Specialty L.P.	BLA	Current
49502-195	SEMGLEE	insulin glargine	Mylan Specialty L.P.	BLA	Current
49502-195	SEMGLEE	insulin glargine	Mylan Specialty L.P.	BLA	Current
49502-195	SEMGLEE	insulin glargine	Mylan Specialty L.P.	BLA	Current
49502-196	SEMGLEE	insulin glargine	Mylan Specialty L.P.	BLA	Current
49502-196	SEMGLEE	insulin glargine	Mylan Specialty L.P.	BLA	Current
49502-196	SEMGLEE	insulin glargine	Mylan Specialty L.P.	BLA	Current
49502-196	SEMGLEE	insulin glargine	Mylan Specialty L.P.	BLA	Current
50090-5835	SEMGLEE	insulin glargine	A-S Medication Solutions	BLA	Current