Product Details for: Hylenex recombinant
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Infiltration, Interstitial, Intramuscular, Intraocular, Peribulbar, Retrobulbar, Soft Tissue, Subcutaneous
150UNITS/ML
Single-Dose Vial
351(a)
Hylenex recombinant
Rx
Proper Name
hyaluronidase human
hyaluronidase human
BLA Number
021859
021859
Applicant
Halozyme Therapeutics, Inc.
Halozyme Therapeutics, Inc.
Original Approval Date
December 2, 2005
December 2, 2005
Date of First Licensure