An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
12/08/2023	SUPPL-108	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019640s108lbl.pdf
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

Top