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Medicines · US (FDA)
Antiepileptics

FDA 2023

Carboxamide derivatives

Rufinamide

Approved 16 Jun 2023OralTablet

The FDA lists this product in 23 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: RUFINAMIDE 400MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

RUFINAMIDE 40MG/ML · SuspensionANDA216549-001 · Prescription
RUFINAMIDE 400MG · TabletThis page
RUFINAMIDE 200MG · TabletANDA217230-001 · Prescription
RUFINAMIDE 200MG · TabletANDA204964-002 · Prescription
RUFINAMIDE 400MG · TabletANDA204964-003 · Prescription
RUFINAMIDE 100MG · TabletANDA204964-001 · Prescription
RUFINAMIDE 40MG/ML · SuspensionANDA216841-001 · Prescription
RUFINAMIDE 200MG · TabletANDA205075-001 · Prescription
RUFINAMIDE 400MG · TabletANDA205075-002 · Prescription
RUFINAMIDE 200MG · TabletANDA204988-001 · Prescription
RUFINAMIDE 400MG · TabletANDA204988-002 · Prescription
RUFINAMIDE 40MG/ML · SuspensionANDA214009-001 · Prescription

More in antiepileptics

BrivaracetamSolution

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

RUFINAMIDE 200MG · TabletANDA216688-001 · Prescription

RUFINAMIDE 400MG · TabletANDA216688-002 · Prescription

RUFINAMIDE 400MG · TabletANDA204993-002 · Prescription

RUFINAMIDE 200MG · TabletANDA204993-001 · Prescription

RUFINAMIDE 400MG · TabletANDA205095-002 · Prescription

RUFINAMIDE 200MG · TabletANDA205095-001 · Prescription

RUFINAMIDE 40MG/ML · SuspensionANDA213457-001 · Prescription

RUFINAMIDE 40MG/ML · SuspensionANDA211388-001 · Prescription

RUFINAMIDE 40MG/ML · SuspensionANDA213410-001 · Prescription

RUFINAMIDE 40MG/ML · SuspensionANDA207363-001 · Prescription

RUFINAMIDE 40MG/ML · SuspensionANDA214817-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA217230.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Rufinamide
Drug class: Carboxamide derivatives
Group: Antiepileptics
Route: Oral
Dosage form: Tablet
Applicant: Aurobindo Pharma
Status: Prescription
FDA approval: 16 Jun 2023
Application: ANDA217230-002
RxCUI: 69036

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