KLOXXADO (NALOXONE HCL)
Summary
FDA approved KLOXXADO (NALOXONE HCL) by HIKMA. NDA (New Drug) approval (Efficacy) on 2025-08-25. SPRAY, NASAL.
Details
Source
Drug Approval
External ID
NDA212045-5
Action Date
2025-08-25
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
KLOXXADO (generic: NALOXONE HCL), SPRAY, NASAL. Application: NDA212045
Company
Context & Analysis
HIKMA has 117 FDA actions in our database.
Frequently Asked Questions
How often does HIKMA have FDA actions?
HIKMA has 117 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 "NDA212045-5" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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