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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761373
Company: SAMSUNG BIOEPIS CO LTD

Medication Guide

Products on BLA 761373

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761373

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373Orig1s000;761425Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761373Orig1s000;761425Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761373Orig1s000,761425Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373s003,761425s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761373Orig1s003, 761425Orig1s003ltr.pdf
12/20/2024	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s002,761425s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761373Orig1s002,761425Orig1s002ltr.pdf

Labels for BLA 761373

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373s003,761425s003lbl.pdf
03/13/2025	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373s003,761425s003lbl.pdf
12/20/2024	SUPPL-2	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s002,761425s002lbl.pdf
06/28/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373Orig1s000;761425Orig1s000correctedlbl.pdf

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