NDA 208411, held by Emergent. Naloxone Hydrochloride.
As of Nov 14, 2026, NDA 208411 (Narcan), held by Emergent, was first approved by FDA on Nov 18, 2015, with 8 approved supplements and 0 published complete response letters.
USES to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life
| Mar 29, 2023 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jan 24, 2017 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2015 | Original applicationNew dosage form · Priority review | Approved |
| Narcan4MG/SPRAY · spray, metered;nasal | Naloxone Hydrochloride | OTCReference drug |
| Narcan2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · spray, metered;nasal | Naloxone Hydrochloride | DiscontinuedReference drug |
| Feb 11, 2026 | Supplement 11Labeling · Standard review | Approved | |
| Jan 9, 2026 | Supplement 10Labeling · Standard review | Approved | |
| Nov 21, 2025 | Supplement 9Labeling · Standard review | Approved | |
| Mar 29, 2023 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Mar 27, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Aug 6, 2020 | Supplement 4Manufacturing | Approved | |
| Sep 23, 2019 | Supplement 2Manufacturing | Approved | |
| Jan 24, 2017 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2015 | Original applicationNew dosage form · 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
