Biologic License Application (BLA): 761103
Company: PFIZER INC

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

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761103s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761103Orig1s000TOC.html

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2026	SUPPL-20	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761103Orig1s020ltr.pdf
06/09/2025	SUPPL-14	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761103s014lbl.pdf
10/16/2023	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761103s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761103Orig1s011ltr.pdf
11/15/2021	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761103s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761103Orig1s005ltr.pdf
05/26/2020	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761103s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761103Orig1s003ltr.pdf

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
06/09/2025	SUPPL-14	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761103s014lbl.pdf
10/16/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761103s011lbl.pdf
11/15/2021	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761103s005lbl.pdf
05/26/2020	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761103s003lbl.pdf
07/23/2019	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761103s000lbl.pdf