NDA 217722, held by Harm Reduction Therp. Naloxone Hydrochloride.
As of Nov 13, 2026, NDA 217722 (Rivive), held by Harm Reduction Therp, was first approved by FDA on Jul 28, 2023, with 0 approved supplements and 0 published complete response letters.
Uses
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2023 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rivive3MG/SPRAY · spray, metered;nasal | Naloxone Hydrochloride | OTCReference 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
