Drug application
AMPHADASE (HYALURONIDASE)
Drugs@FDA BLA 021665 · AMPHASTAR PHARM
Key facts
| Drug name | AMPHADASE |
|---|---|
| Active ingredients | HYALURONIDASE |
| Application type | BLA |
| Application number | 021665 |
| Company | AMPHASTAR PHARM |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 150 UNITS/ML |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 1 - New Molecular Entity |
| Latest submission status date | Oct 26, 2004 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 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: