NDA 213225, held by Sun Pharm. Leuprolide Acetate.
As of Nov 13, 2026, NDA 213225 (Vobrig), held by Sun Pharm, was first approved by FDA on Aug 26, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vobrig28MG/2.8ML (10MG/ML) · solution;subcutaneous | Leuprolide Acetate | DiscontinuedReference drug |
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
