Drug application
ZORBTIVE (SOMATROPIN RECOMBINANT)
Drugs@FDA BLA 021597 · EMD SERONO
Key facts
| Drug name | ZORBTIVE |
|---|---|
| Active ingredients | SOMATROPIN RECOMBINANT |
| Application type | BLA |
| Application number | 021597 |
| Company | EMD SERONO |
| Dosage forms | INJECTABLE, INJECTION |
| Strength | 4MG/VIAL |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 6 - New Indication (no longer used) |
| Latest submission status date | Dec 1, 2003 |
At a glance
- 1–9 Submissions
- 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: