FDA.reportPublic FDA data

Application 761121

Type
BLA
Sponsor
GENENTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761121Polivypolatuzumab vedotin-piiq351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLIVYPOLATUZUMAB VEDOTIN-PIIQINJECTABLE;INJECTION140MGNoNo
002POLIVYPOLATUZUMAB VEDOTIN-PIIQPOWDER;INTRAVENOUS30MG/VIALNoNo

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
POLIVYPOLATUZUMAB VEDOTINGenentech, Inc.20a16ab2-f338-4abb-9dcd-254bd949a2bc2026-03-24Warnings, Adverse reactionsExact identifier
application number: BLA761121
ndc (product): 50242-105
ndc (product): 50242-103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-103POLIVYpolatuzumab vedotinGenentech, Inc.BLACurrent
50242-103POLIVYpolatuzumab vedotinGenentech, Inc.BLACurrent
50242-105POLIVYpolatuzumab vedotinGenentech, Inc.BLACurrent
50242-105POLIVYpolatuzumab vedotinGenentech, Inc.BLACurrent
50242-105POLIVYpolatuzumab vedotinGenentech, Inc.BLACurrent
50242-105POLIVYpolatuzumab vedotinGenentech, Inc.BLACurrent
50242-105POLIVYpolatuzumab vedotinGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85483SUPPL 2026-03-24
85430SUPPL 2026-03-20
77697SUPPL 2024-03-04
74033SUPPL 2023-04-20
74031SUPPL 2023-04-20
65898SUPPL2021-01-12
65896SUPPL2021-01-12
59227ORIG2019-07-03
59226ORIG2019-07-02
58998ORIG2019-06-10