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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 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.
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 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
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) |
| HYLENEX RECOMBINANT | hyaluronidase recombinant human | INJECTABLE;INJECTION | 021859 | NDA | A-S Medication Solutions | 50090-4534 | 50090-4534-0 | 1 mL in 1 VIAL (50090-4534-0) |
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: | Start Trial | Patent Expiration: | Sep 23, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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