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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021859

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NDA 021859 describes HYLENEX RECOMBINANT, which is a drug marketed by Halozyme Therap and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the HYLENEX RECOMBINANT profile page.

The generic ingredient in HYLENEX RECOMBINANT is hyaluronidase recombinant human. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hyaluronidase recombinant human profile page.
Summary for 021859
Tradename:HYLENEX RECOMBINANT
Applicant:Halozyme Therap
Ingredient:hyaluronidase recombinant human
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021859
Ingredient-typeGlycoside Hydrolases
Suppliers and Packaging for NDA: 021859
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYLENEX RECOMBINANT hyaluronidase recombinant human INJECTABLE;INJECTION 021859 NDA Halozyme, Inc. 18657-117 18657-117-04 4 BOX in 1 CARTON (18657-117-04) > 1 VIAL in 1 BOX (18657-117-02) > 1 mL in 1 VIAL (18657-117-01)
HYLENEX RECOMBINANT hyaluronidase recombinant human INJECTABLE;INJECTION 021859 NDA Baxter Healthcare Corporation 60977-319 60977-319-03 4 BOX in 1 CARTON (60977-319-03) > 1 VIAL, SINGLE-DOSE in 1 BOX (60977-319-02) > 1 mL in 1 VIAL, SINGLE-DOSE (60977-319-44)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150 UNITS/ML
Approval Date:Dec 2, 2005TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Sep 23, 2027Product Flag?YSubstance Flag?YDelist Request?

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US Army
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Daiichi Sankyo
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Covington

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