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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 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 NDA: 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. 18657-102 18657-102-04 4 BOX in 1 CARTON (18657-102-04) > 1 VIAL in 1 BOX (18657-102-02) > 1 mL in 1 VIAL (18657-102-01)
HYLENEX RECOMBINANT
hyaluronidase recombinant human
INJECTABLE;INJECTION 021859 NDA Halozyme, Inc. 18657-102 18657-102-10 10 BOX in 1 CARTON (18657-102-10) > 1 VIAL in 1 BOX (18657-102-02) > 1 mL in 1 VIAL (18657-102-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150 UNITS/ML
Approval Date:Dec 2, 2005TE:RLD:Yes
Patent:7,767,429Patent Expiration:Sep 23, 2027Product Flag?YSubstance Flag?YDelist Request?


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