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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761054
Company: SAMSUNG BIOEPIS CO LTD

Medication Guide

Products on BLA 761054

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RENFLEXIS	INFLIXIMAB-ABDA	100MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761054

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2017	ORIG-1	Approval		N/A	Label Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761054Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761054Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2022	SUPPL-29	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761054Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761054Orig1s029ltr.pdf
12/26/2023	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761054s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761054Orig1s021Correctedltr.pdf
06/26/2019	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761054Orig1s009ltr.pdf
03/21/2019	SUPPL-4	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s004lbl.pdf

Labels for BLA 761054

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2023	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761054s021lbl.pdf
12/26/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761054s021lbl.pdf
01/27/2022	SUPPL-29	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761054Orig1s029lbl.pdf
06/26/2019	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s009lbl.pdf
03/21/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s004lbl.pdf
04/21/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000lbledt.pdf
04/21/2017	ORIG-1	Approval			https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000TOC.cfm

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