Biologic License Application (BLA): 761140
Company: AMGEN INC

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

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2020	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761140s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761140Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761140Orig1s000TOC.html

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2026	SUPPL-5	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761140Orig1s005ltr.pdf
06/09/2025	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761140s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761140Orig1s004ltr.pdf
06/03/2022	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761140s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761140Orig1s001ltr.pdf

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
06/09/2025	SUPPL-4	Bioequivalence	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761140s004lbl.pdf
06/03/2022	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761140s001lbl.pdf
12/17/2020	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761140s000lbl.pdf