Drug application
STARJEMZA (USTEKINUMAB-HMNY)
Drugs@FDA BLA 761419 · BIO-THERA SOLUTIONS LTD
Key facts
| Drug name | STARJEMZA |
|---|---|
| Active ingredients | USTEKINUMAB-HMNY |
| Application type | BLA |
| Application number | 761419 |
| Company | BIO-THERA SOLUTIONS LTD |
| Dosage forms | INJECTABLE, SUBCUTANEOUS |
| Strength | 45MG/0.5ML |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 2 - New Active Ingredient |
| Latest submission status date | May 22, 2025 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No 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: