Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761364
Company: ACCORD BIOPHARMA INC.

Products on BLA 761364

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761364

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761364s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761364Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761364Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2025	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761364s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761364Orig1s001ltr.pdf

Labels for BLA 761364

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2025	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761364s001lbl.pdf
03/17/2025	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761364s001lbl.pdf
10/10/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761364s000lbl.pdf