← FDA DRUG APPROVALS

FDA NDA · NDA212045

KLOXXADO

naloxone hcl

Sponsor: HIKMA

APPLICATION
NDA212045
TYPE
NDA
ORIGINAL APPROVAL
2021-04-29
LATEST ACTION
2025-08-25
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

KLOXXADO · ReferencePrescription
NALOXONE HYDROCHLORIDE 8MG/SPRAY · SPRAY · NASAL
KLOXXADO · ReferencePrescription
NALOXONE HYDROCHLORIDE 4MG/SPRAY · SPRAY · NASAL

Approval history

2025-08-25Efficacy · Supplement 5 · standard — Letter ↗AP
2021-04-29Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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