Drug application
SAIZEN (SOMATROPIN)
Drugs@FDA BLA 019764 · EMD SERONO
Key facts
| Drug name | SAIZEN |
|---|---|
| Active ingredients | SOMATROPIN |
| Application type | BLA |
| Application number | 019764 |
| Company | EMD SERONO |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 6MG/VIAL |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Oct 8, 1996 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 10–99 Label versions
- 1–9 Products
- None Therapeutic equivalents
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: