BLA 21484, held by Ferring. Urofollitropin.
As of Nov 13, 2026, BLA 21484 (Bravelle), held by Ferring, was first approved by FDA on Dec 19, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2002 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bravelle0.9% · injectable; subcutaneous | Urofollitropin | 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
