NDA 218379, held by Adventapharma. Diclofenac Sodium.
As of Nov 14, 2026, NDA 218379 (Zueino), held by Adventapharma, was first approved by FDA on Sep 25, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 25, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zueino37.5MG/ML (37.5MG/ML) · solution;intravenous | Diclofenac Sodium | RxReference 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
