Drug application
ACTEMRA (TOCILIZUMAB)
Drugs@FDA BLA 125472 · GENENTECH
Key facts
| Drug name | ACTEMRA |
|---|---|
| Active ingredients | TOCILIZUMAB |
| Application type | BLA |
| Application number | 125472 |
| Company | GENENTECH |
| Dosage forms | INJECTABLE, INTRAVENOUS, SUBCUTANEOUS |
| Strength | 162MG/0.9ML |
| Marketing status | Prescription |
| Reference listed drug | No |
| Latest submission class | Type 3 - New Dosage Form |
| Latest submission status date | Oct 21, 2013 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 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: