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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019640
Company: LILLY

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

Products on BLA 19640

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HUMATROPE	SOMATROPIN	2MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
HUMATROPE	SOMATROPIN	5MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
HUMATROPE	SOMATROPIN	6MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
HUMATROPE	SOMATROPIN	12MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
HUMATROPE	SOMATROPIN	24MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No

Labels for BLA 019640

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2019	SUPPL-105	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf
10/28/2019	SUPPL-105	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf
10/28/2019	SUPPL-105	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf
10/28/2019	SUPPL-91	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf
12/13/2016	SUPPL-104	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019640s104lbl.pdf
07/30/2014	SUPPL-92	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019640s092lbl.pdf
08/22/2011	SUPPL-86	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s086lbl.pdf
02/23/2011	SUPPL-84	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s084lbl.pdf
07/28/2010	SUPPL-78	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019640s078_2lbl.pdf
03/12/2009	SUPPL-68	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019640s068lbl.pdf
11/01/2006	SUPPL-58	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s058lbl.pdf
10/26/2006	SUPPL-52	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf
10/26/2006	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf
10/26/2006	SUPPL-47	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf
10/12/2005	SUPPL-45	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019640s045lbl.pdf
09/22/2004	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19640s040lbl.pdf
07/25/2003	SUPPL-33	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19640se1-033_humatropen_lbl.pdf

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