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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

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
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)
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)

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.