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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761406
Company: BIOCON BIOLOGICS INC

Medication Guide

Products on BLA 761406

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
YESINTEK	USTEKINUMAB-KFCE	45MG/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
YESINTEK	USTEKINUMAB-KFCE	90MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761406

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	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761406Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761406Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761406Orig1Orig2s000TOC.html
11/29/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761406s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761406Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761406Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761406Orig1Orig2s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2026	SUPPL-1	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761406s001lbl.pdf

Labels for BLA 761406

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2026	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761406s001lbl.pdf
01/07/2026	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761406s001lbl.pdf
04/30/2025	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761406Orig2s000lbl.pdf
11/29/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761406s000lbl.pdf

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