FDA.reportPublic FDA data

Application 761170

Type
BLA
Sponsor
GENENTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761170Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxf351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHESGOPERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXFINJECTABLE;INTRAVENOUS, SUBCUTANEOUS1200MG;600MG;30000UNITSNoNo
002PHESGOPERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXFINJECTABLE;SUBCUTANEOUS600MG;600MG;20,000UNITSNoNo

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
PhesgoPERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXFGenentech, Inc.27dd5e6b-72cd-458d-a015-cf4dab5800da2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761170
ndc (product): 50242-260
ndc (product): 50242-245

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-245Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.BLACurrent
50242-245Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.BLACurrent
50242-245Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.BLACurrent
50242-245Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.BLACurrent
50242-260Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.BLACurrent
50242-260Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.BLACurrent
50242-260Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.BLACurrent
50242-260Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85983SUPPL 2026-05-19
85979SUPPL 2026-05-19
80429SUPPL 2024-11-26
80357SUPPL 2024-11-25
65579ORIG2020-12-11
63827ORIG2020-07-08
63759ORIG2020-06-30