Application 020604

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEROSTIM	SOMATROPIN	INJECTABLE;INJECTION	6MG/VIAL	No	No
002	SEROSTIM	SOMATROPIN	INJECTABLE;INJECTION	5MG/VIAL	No	No
003	SEROSTIM	SOMATROPIN	INJECTABLE;INJECTION	4MG/VIAL	No	No
004	SEROSTIM	SOMATROPIN	INJECTABLE;INJECTION	8.8MG/VIAL	No	No
005	SEROSTIM LQ	SOMATROPIN	INJECTABLE;SUBCUTANEOUS	6MG/0.5ML (6MG/0.5ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44087-0004	Serostim	somatropin	EMD Serono, Inc.	BLA	Current
44087-0004	Serostim	somatropin	EMD Serono, Inc.	BLA	Current
44087-0004	Serostim	somatropin	EMD Serono, Inc.	NDA	Current
44087-0004	Serostim	somatropin	EMD Serono, Inc.	NDA	Current
44087-0005	Serostim	somatropin	EMD Serono, Inc.	BLA	Current
44087-0005	Serostim	somatropin	EMD Serono, Inc.	BLA	Current
44087-0005	Serostim	somatropin	EMD Serono, Inc.	NDA	Current
44087-0005	Serostim	somatropin	EMD Serono, Inc.	NDA	Current
44087-0006	Serostim	somatropin	EMD Serono, Inc.	BLA	Current
44087-0006	Serostim	somatropin	EMD Serono, Inc.	BLA	Current
44087-0006	Serostim	somatropin	EMD Serono, Inc.	NDA	Current
44087-0006	Serostim	somatropin	EMD Serono, Inc.	NDA	Current