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Details for New Drug Application (NDA): 021859
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 |
Pharmacology for NDA: 021859
Ingredient-type | Glycoside 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 | N | 18657-117-04 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 150 UNITS/ML | ||||
Approval Date: | Dec 2, 2005 | TE: | RLD: | Yes | |||||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Sep 23, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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