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): 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.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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
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
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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf
08/25/2008	SUPPL-4	Labeling-Package Insert	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.

Top