FDA.reportPublic FDA data

Application 761103

Type
BLA
Sponsor
PFIZER INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761103Ruxiencerituximab-pvvr351(k) BiosimilarRx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RUXIENCERITUXIMAB-PVVRINJECTABLE;INJECTION100MG/10ML(10MG/ML)NoNo
002RUXIENCERITUXIMAB-PVVRINJECTABLE;INJECTION500MG/50ML(10MG/ML)NoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RuxienceRITUXIMAB-PVVRPfizer Laboratories Div Pfizer Incf941fc61-f7a3-4e4a-ab7c-87c1667fa05b2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761103
ndc (product): 0069-0249
ndc (product): 0069-0238

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0238Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0238Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0238Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0249Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0249Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0249Ruxiencerituximab-pvvrPfizer Laboratories Div Pfizer IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82525SUPPL 2025-06-10
82524SUPPL 2025-06-10
75866SUPPL 2023-10-20
75831SUPPL 2023-10-17
69336SUPPL2021-11-17
69321SUPPL2021-11-16
69320SUPPL2021-11-16
63330SUPPL2020-05-29
63307SUPPL2020-05-27
63306SUPPL2020-05-27
59773ORIG2019-08-20
59442ORIG2019-08-20
59406ORIG2019-07-23
59405ORIG2019-07-23