NDA 215457, held by Kaleo Inc. Naloxone Hydrochloride.
As of Nov 14, 2026, NDA 215457 (Naloxone Hydrochloride (Autoinjector)), held by Kaleo Inc, was first approved by FDA on Feb 28, 2022, with 1 approved supplement and 0 published complete response letters.
NALOXONE HYDROCHLORIDE injection is indicated for use by military personnel and chemical incident responders for: Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2022 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naloxone Hydrochloride (Autoinjector)10MG/0.4ML (10MG/0.4ML) · solution;intramuscular, subcutaneous | Naloxone Hydrochloride | DiscontinuedReference drug |
| Apr 3, 2023 | Supplement 1Manufacturing | Approved | |
| Feb 28, 2022 | Original applicationNew formulation or manufacturer · Priority 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
