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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021426
Company: SANDOZ

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

Products on BLA 21426

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMNITROPE	SOMATROPIN	5.8MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
OMNITROPE	SOMATROPIN	1.5MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
OMNITROPE	SOMATROPIN	5MG/1.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
OMNITROPE	SOMATROPIN	10MG/1.5ML	INJECTABLE;INJECTION	Prescription	None	No	No

Labels for BLA 021426

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2025	SUPPL-62	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021426s062lbl.pdf
11/12/2024	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021426s043lbl.pdf
02/15/2017	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021426s022lbl.pdf
12/13/2016	SUPPL-34	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf
12/13/2016	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf
08/29/2014	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021426s028lbl.pdf
07/22/2011	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s017lbl.pdf
04/13/2011	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s018lbl.pdf
08/26/2010	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s015lbl.pdf
04/23/2010	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf
04/23/2010	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf
03/25/2009	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf
03/25/2009	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf
08/25/2008	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf
08/25/2008	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf
01/16/2008	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf
01/16/2008	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf
05/30/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021426lbl.pdf

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