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FDA NDA · NDA208969

REXTOVY

naloxone hydrochloride

Sponsor: AMPHASTAR PHARMS INC

APPLICATION
NDA208969
TYPE
NDA
ORIGINAL APPROVAL
2023-03-07
LATEST ACTION
2026-06-16
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Over-the-counter

Products

REXTOVY · ReferenceOver-the-counter
NALOXONE HYDROCHLORIDE 4MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2026-06-16Efficacy · Supplement 2 · standard — Label ↗AP
2023-06-29Labeling · Supplement 1 · standard — Letter ↗AP
2023-03-07Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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