Drug application
Hyaluronidase human recombinant for further manufacturing use (Hyaluronidase human recombinant for further manufacturing use)
Drugs@FDA BLA 761313 · HALOZYME THERAP
Key facts
| Drug name | Hyaluronidase human recombinant for further manufacturing use |
|---|---|
| Active ingredients | Hyaluronidase human recombinant for further manufacturing use |
| Application type | BLA |
| Application number | 761313 |
| Company | HALOZYME THERAP |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 10MG/ML |
| Marketing status | For Further Manufacturing Use |
| Reference listed drug | Yes |
| Latest submission status date | Jun 20, 2023 |
At a glance
- 1–9 Submissions
- None Label versions
- None Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: