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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761088
Company: CELLTRION INC

Medication Guide

Products on BLA 761088

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRUXIMA	RITUXIMAB-ABBS	100MG/10ML(10MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No
TRUXIMA	RITUXIMAB-ABBS	500MG/50ML(10MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761088

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/2018	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761088s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761088Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761088Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2022	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761088s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761088Orig1s018ltr.pdf
05/29/2020	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761088s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761088Orig1s009ltr.pdf
12/18/2019	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761088Orig1s005, s006ltr.pdf
12/18/2019	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761088Orig1s005, s006ltr.pdf
05/23/2019	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088Orig1s001s002_Replacementlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761088Orig1s001s002Replacementltr.pdf
05/23/2019	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088Orig1s001s002_Replacementlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761088Orig1s001s002Replacementltr.pdf

Labels for BLA 761088

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2022	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761088s018lbl.pdf
02/04/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761088s018lbl.pdf
05/29/2020	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761088s009lbl.pdf
05/29/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761088s009lbl.pdf
12/18/2019	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088s005s006lbl.pdf
12/18/2019	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088s005s006lbl.pdf
05/23/2019	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088Orig1s001s002_Replacementlbl.pdf
05/23/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761088Orig1s001s002_Replacementlbl.pdf
11/28/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761088s000lbl.pdf

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