FDA.reportPublic FDA data

Application 021859

Type
BLA
Sponsor
HALOZYME THERAP

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
18657-117HYLENEX RecombinantHyaluronidase (Human Recombinant)Halozyme Therapeutics, Inc.BLACurrent
18657-117HYLENEX RecombinantHyaluronidase (Human Recombinant)Halozyme, Inc.BLACurrent
18657-117HYLENEX RecombinantHyaluronidase (Human Recombinant)Halozyme, Inc.NDACurrent
18657-117HYLENEX RecombinantHyaluronidase (Human Recombinant)Halozyme, Inc.NDACurrent
50090-4534HYLENEX RecombinantHyaluronidase (Human Recombinant)A-S Medication SolutionsBLACurrent
50090-4534HYLENEX RecombinantHyaluronidase (Human Recombinant)A-S Medication SolutionsBLACurrent
50090-4534HYLENEX RecombinantHyaluronidase (Human Recombinant)A-S Medication SolutionsNDACurrent
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