| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 021859 | BLA | HALOZYME THERAP | 001 | HYLENEX RECOMBINANT | INJECTABLE;INJECTION | 150 UNITS/ML | HYALURONIDASE RECOMBINANT HUMAN | 2005-12-02 | Prescription | No |