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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/01/2003 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21597,20604slr026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021597s000_ZorbtiveTOC.cfm |
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 |