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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 021426

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2006	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021426lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021426s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021426s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2025	SUPPL-62	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021426s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021426Orig1s062ltr.pdf
11/12/2024	SUPPL-58	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021426Orig1s043, s058ltr.pdf
01/25/2022	SUPPL-50	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021426Orig1s050ltr.pdf
11/12/2024	SUPPL-43	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021426s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021426Orig1s043, s058ltr.pdf
12/13/2016	SUPPL-34	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021426Orig1s034ltr.pdf
07/14/2014	SUPPL-29	Supplement		Label is not available on this site.
08/29/2014	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021426s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021426Orig1s028ltr.pdf
08/22/2013	SUPPL-27	Supplement		Label is not available on this site.
06/18/2013	SUPPL-25	Supplement		Label is not available on this site.
04/04/2013	SUPPL-23	Supplement		Label is not available on this site.
02/15/2017	SUPPL-22	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021426s022lbl.pdf
04/13/2011	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s018ltr.pdf
07/22/2011	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s017ltr.pdf
08/26/2010	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s015ltr.pdf
04/23/2010	SUPPL-8	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s008.pdf
04/23/2010	SUPPL-7	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s007.pdf
03/25/2009	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021426s006ltr.pdf
08/25/2008	SUPPL-4	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s004.pdf
01/16/2008	SUPPL-2	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s002.pdf

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf
12/13/2016	SUPPL-34	Labeling-Medication Guide	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

Therapeutic Equivalents for BLA 021426

OMNITROPE

There are no Therapeutic Equivalents.

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