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Details for New Drug Application (NDA): 021859
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.
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: | ➤ Sign Up | Patent Expiration: | Sep 23, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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