NDA 215487, held by Scienture. Naloxone Hydrochloride.
As of Nov 13, 2026, NDA 215487 (Rezenopy), held by Scienture, was first approved by FDA on Apr 19, 2024, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rezenopy10MG/SPRAY · spray;nasal | Naloxone Hydrochloride | RxReference drug |
| Apr 9, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Apr 19, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
