Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019764
Company: EMD SERONO

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

Products on BLA 19764

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAIZEN	SOMATROPIN	6MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
SAIZEN	SOMATROPIN	5MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
SAIZEN	SOMATROPIN	8.8MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
SAIZEN	SOMATROPIN	4MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for BLA 019764

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2017	SUPPL-86	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s086lbl.pdf
05/08/2017	SUPPL-86	Labeling-Proprietary Name Change	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s086lbl.pdf
01/17/2017	SUPPL-79	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s079lbl.pdf
12/13/2016	SUPPL-83	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s083lbl.pdf
06/18/2014	SUPPL-72	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019764s072lbl.pdf
04/03/2012	SUPPL-49	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019764s049lbl.pdf
10/31/2007	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf
10/31/2007	SUPPL-35	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf
08/27/2007	SUPPL-39	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s039lbl.pdf
08/22/2007	SUPPL-37	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s037lbl.pdf
03/05/2007	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s034lbl.pdf
01/16/2007	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s030lbl.pdf
01/16/2007	SUPPL-30	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s030lbl.pdf
11/01/2004	SUPPL-20	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764s020lbl.pdf
07/09/2004	SUPPL-25	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf
07/01/2003	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19764slr023_saizen_lbl.pdf