REXTOVY (NALOXONE HYDROCHLORIDE)
Summary
FDA approved REXTOVY (NALOXONE HYDROCHLORIDE) by AMPHASTAR PHARMS INC. NDA (New Drug) approval (Efficacy) on 2026-06-16. SPRAY, METERED, NASAL.
Details
Source
Drug Approval
External ID
NDA208969-2
Action Date
2026-06-16
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
REXTOVY (generic: NALOXONE HYDROCHLORIDE), SPRAY, METERED, NASAL. Application: NDA208969
Company
Context & Analysis
AMPHASTAR PHARMS INC has 3 FDA actions in our database.
Frequently Asked Questions
How often does AMPHASTAR PHARMS INC have FDA actions?
AMPHASTAR PHARMS INC has 3 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA208969-2" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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