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)Rx2026-09-01

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

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 ยท 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