FDA NDA · NDA217202

RAPIBLYK

landiolol

Sponsor: AOP HLTH US

APPLICATION

NDA217202

TYPE

NDA

ORIGINAL APPROVAL

2024-11-22

LATEST ACTION

2026-02-13

ROUTE

INTRAVENOUS

DOSAGE FORM

POWDER

MARKETING STATUS

Prescription

Products

RAPIBLYK · ReferencePrescription

LANDIOLOL HYDROCHLORIDE EQ 280MG BASE/VIAL · POWDER · INTRAVENOUS

2026-02-13Efficacy · Supplement 1 · standard — Letter ↗AP

2024-11-22Type 1 - New Molecular Entity · 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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