FDA NDA · NDA215487

REZENOPY

naloxone hcl

Sponsor: SCIENTURE

APPLICATION

NDA215487

TYPE

NDA

ORIGINAL APPROVAL

2024-04-19

LATEST ACTION

2026-04-09

ROUTE

NASAL

DOSAGE FORM

SPRAY

MARKETING STATUS

Prescription

Products

REZENOPY · ReferencePrescription

NALOXONE HYDROCHLORIDE 10MG/SPRAY · SPRAY · NASAL

2026-04-09Labeling · Supplement 2 · standard — Letter ↗AP

2024-04-19Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP

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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