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): 761338
Company: CELLTRION, INC.

Medication Guide

Products on BLA 761338

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STEQEYMA	USTEKINUMAB-STBA	45MG/0.5ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
STEQEYMA	USTEKINUMAB-STBA	90MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
STEQEYMA	USTEKINUMAB-STBA	130MG/26ML	INJECTABLE;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2025	ORIG-2	Approval		N/A	Letter (PDF) Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761338Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761338Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761338Orig1Orig2s000TOC.cfm
12/17/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761338s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761338Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761338Orig1Orig2s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761338Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761338Orig1s003ltr.pdf
04/28/2025	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761338s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761338Orig1s001ltr.pdf

Labels for BLA 761338

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2025	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761338Orig1s003lbl.pdf
04/28/2025	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761338s001lbl.pdf
12/17/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761338s000lbl.pdf

Top