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Generated: November 20, 2018

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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 one supplier. 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. One supplier is 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
Generic Entry Opportunity Date for 021859
Generic Entry Date for 021859*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INJECTION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)

Profile for product number 001

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

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