BLA 21597, held by Emd Serono. Somatropin Recombinant.
As of Nov 13, 2026, BLA 21597 (Zorbtive), held by Emd Serono, was first approved by FDA on Dec 1, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 1, 2003 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zorbtive4MG/VIAL · injectable;injection | Somatropin Recombinant | Discontinued |
| Zorbtive5MG/VIAL · injectable;injection | Somatropin Recombinant | Discontinued |
| Zorbtive6MG/VIAL · injectable;injection | Somatropin Recombinant | Discontinued |
| Zorbtive8.8MG/VIAL · injectable;injection | Somatropin Recombinant | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
