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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125544
Company: CELLTRION INC

Medication Guide

Products on BLA 125544

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125544

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2016	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125544Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125544Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2025	SUPPL-55	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125544s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125544Orig1s055ltr.pdf
06/17/2021	SUPPL-18	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125544s018lbl.pdf
06/18/2019	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125544s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125544Orig1s009ltr.pdf
07/27/2018	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125544s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125544Orig1s008Ltr.pdf

Labels for BLA 125544

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2025	SUPPL-55	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125544s055lbl.pdf
06/17/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125544s018lbl.pdf
06/18/2019	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125544s009lbl.pdf
07/27/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125544s008lbl.pdf
07/27/2018	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125544s008lbl.pdf
04/05/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf

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