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NARCAN (NALOXONE HYDROCHLORIDE NASAL)

EMERGENT

Summary

FDA approved NARCAN (NALOXONE HYDROCHLORIDE NASAL) by EMERGENT. NDA (New Drug) approval (Labeling) on 2026-02-11. SPRAY, METERED, NASAL.

Details

Source

Drug Approval

External ID

NDA208411-11

Action Date

2026-02-11

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

NARCAN (generic: NALOXONE HYDROCHLORIDE NASAL), SPRAY, METERED, NASAL. Application: NDA208411

Company

Context & Analysis

Frequently Asked Questions

How often does EMERGENT have FDA actions?

This is the only FDA action we have on record for EMERGENT in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA208411-11" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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