FDA.reportPublic FDA data

Application 761106

Type
BLA
Sponsor
GENENTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761106Herceptin Hylectatrastuzumab and hyaluronidase-oysk351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HERCEPTIN HYLECTATRASTUZUMAB; HYALURONIDASE-OYSKINJECTABLE;SUBCUTANEOUS600MG;10000UNITSNoNo

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
Herceptin HylectaTRASTUZUMAB AND HYALURONIDASE-OYSKGenentech, Inc.ebf30894-41cf-480c-8bc3-56f592a138132026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761106
ndc (product): 50242-077

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-077Herceptin HylectaTrastuzumab and hyaluronidase-oyskGenentech, Inc.BLACurrent
50242-077Herceptin HylectaTrastuzumab and hyaluronidase-oyskGenentech, Inc.BLACurrent
50242-077Herceptin HylectaTrastuzumab and hyaluronidase-oyskGenentech, Inc.BLACurrent
50242-077Herceptin HylectaTrastuzumab and Hyaluronidase-oyskGenentech, Inc.BLACurrent
50242-077Herceptin HylectaTrastuzumab and hyaluronidase-oyskGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85986SUPPL 2026-05-19
85975SUPPL 2026-05-19
78852SUPPL 2024-06-20
78831SUPPL 2024-06-20
60577ORIG2019-10-17
57864ORIG2019-03-01
57834ORIG2019-02-28