Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021597
Company: EMD SERONO
Company: EMD SERONO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZORBTIVE | SOMATROPIN RECOMBINANT | 4MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ZORBTIVE | SOMATROPIN RECOMBINANT | 5MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ZORBTIVE | SOMATROPIN RECOMBINANT | 6MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ZORBTIVE | SOMATROPIN RECOMBINANT | 8.8MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/01/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf |