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FDA NDA · NDA208411

NARCAN

naloxone hydrochloride nasal

Sponsor: EMERGENT

APPLICATION
NDA208411
TYPE
NDA
ORIGINAL APPROVAL
2015-11-18
LATEST ACTION
2026-02-11
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter, Discontinued

Products

NARCAN · ReferenceOver-the-counter
NALOXONE HYDROCHLORIDE 4MG/SPRAY · SPRAY, METERED · NASAL
NARCAN · ReferenceDiscontinued
NALOXONE HYDROCHLORIDE 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2026-02-11Labeling · Supplement 11 · standard — Letter ↗AP
2026-01-09Labeling · Supplement 10 · standard — Label ↗AP
2025-11-21Labeling · Supplement 9 · standard — Label ↗AP
2023-03-29Efficacy · Supplement 6 · priority — Label ↗AP
2023-03-27Labeling · Supplement 7 · standard — Letter ↗AP
2020-08-06Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2019-09-23Manufacturing (CMC) · Supplement 2 — Label ↗AP
2017-01-24Efficacy · Supplement 1 · standard — Label ↗AP
2015-11-18Type 3 - New Dosage Form · Original · priority — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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