NDA 209862, held by Kaleo Inc. Naloxone Hydrochloride.
As of Nov 14, 2026, NDA 209862 (Evzio (Autoinjector)), held by Kaleo Inc, was first approved by FDA on Oct 19, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2016 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Evzio (Autoinjector)2MG/0.4ML (2MG/0.4ML) · solution;intramuscular, subcutaneous | Naloxone Hydrochloride | 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
