FDA.reportPublic FDA data

Application 021859

Type
BLA
Sponsor
HALOZYME THERAP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021859Hylenex recombinanthyaluronidase human351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYLENEX RECOMBINANTHYALURONIDASE RECOMBINANT HUMANINJECTABLE;INJECTION150 UNITS/MLNoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYLENEX RecombinantHYALURONIDASEAntares Pharma, Inc.3023cc56-ed4b-4e87-b3a1-81b20943f6582024-11-11Warnings, Adverse reactionsExact identifier
application number: BLA021859
ndc (product): 18657-117
HYALURONIDASEHYALURONIDASEHF Acquisition Co LLC, DBA HealthFirstc3f1db01-58bf-2226-e053-2a95a90a8b332021-06-04Warnings, Adverse reactionsExact identifier
application number: BLA021859
ndc (product): 51662-1555

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
18657-117HYLENEX RecombinantHyaluronidase (Human Recombinant)Halozyme, Inc.NDACurrent
18657-117HYLENEX RecombinantHyaluronidase (Human Recombinant)Halozyme Therapeutics, Inc.BLACurrent
18657-117HYLENEX RecombinantHyaluronidase (Human Recombinant)Halozyme, Inc.NDACurrent
18657-117HYLENEX RecombinantHyaluronidase (Human Recombinant)Halozyme, Inc.BLACurrent
50090-4534HYLENEX RecombinantHyaluronidase (Human Recombinant)A-S Medication SolutionsBLACurrent
50090-4534HYLENEX RecombinantHyaluronidase (Human Recombinant)A-S Medication SolutionsNDACurrent
50090-4534HYLENEX RecombinantHyaluronidase (Human Recombinant)A-S Medication SolutionsBLACurrent
51662-1555HYALURONIDASEHYALURONIDASEHF Acquisition Co LLC, DBA HealthFirstBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77217SUPPL 2024-01-16
77215SUPPL 2024-01-16
62338APPL2020-03-25
42328ORIG2020-03-23
37770SUPPL2020-03-23
28723SUPPL2020-03-23
28722SUPPL2020-03-23
16470SUPPL2020-03-23
16469SUPPL2020-03-23
16468SUPPL2020-03-23
16467SUPPL2020-03-23
16466ORIG2020-03-23
6321SUPPL2020-03-23
6320SUPPL2020-03-23
6319SUPPL2020-03-23
6318SUPPL2020-03-23
6317ORIG2020-03-23