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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020604
Company: EMD SERONO

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 20604

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEROSTIM	SOMATROPIN	6MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
SEROSTIM	SOMATROPIN	5MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
SEROSTIM	SOMATROPIN	4MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
SEROSTIM	SOMATROPIN	8.8MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
SEROSTIM LQ	SOMATROPIN	6MG/0.5ML (6MG/0.5ML)	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No

Labels for BLA 020604

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2026	SUPPL-104	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020604s104lbl.pdf
07/14/2026	SUPPL-104	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020604s104lbl.pdf
05/24/2017	SUPPL-74	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s074lbl.pdf
05/09/2017	SUPPL-93	Labeling-Proprietary Name Change	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s093lbl.pdf
05/09/2017	SUPPL-93	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s093lbl.pdf
12/13/2016	SUPPL-90	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s090lbl.pdf
12/13/2016	SUPPL-89	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s089lbl.pdf
06/18/2014	SUPPL-78	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020604s078lbl.pdf
04/03/2012	SUPPL-49	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020604s049lbl.pdf
08/30/2007	SUPPL-44	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044lbl.pdf
08/30/2007	SUPPL-44	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044_2lbl.pdf
07/13/2007	SUPPL-40	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s040lbl.pdf
11/27/2006	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s035lbl.pdf
09/21/2006	SUPPL-34	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s034lbl.pdf
08/24/2005	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020604s031lbl.pdf
02/11/2005	SUPPL-29	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20604s029lbl.pdf
07/09/2004	SUPPL-30	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf
12/01/2003	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf
08/29/2003	SUPPL-27	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604se7-027_serostim_lbl.pdf

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