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Medicines · US (FDA)

FDA 2024

FDA

Primidone

Approved 23 Jan 2024OralTablet

The FDA lists this product in 21 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: PRIMIDONE 50MG

Strengths and forms

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

PRIMIDONE 250MG · TabletANDA085052-001 · Discontinued
PRIMIDONE 250MG · TabletANDA218366-002 · Prescription
PRIMIDONE 50MG · TabletThis page
PRIMIDONE 125MG · TabletANDA214896-003 · Prescription
PRIMIDONE 50MG · TabletANDA214896-001 · Prescription
PRIMIDONE 250MG · TabletANDA214896-002 · Prescription
PRIMIDONE 50MG · TabletANDA040866-001 · Prescription
PRIMIDONE 250MG · TabletANDA040866-002 · Prescription
PRIMIDONE 50MG · TabletANDA084903-002 · Prescription
PRIMIDONE 250MG · TabletANDA084903-001 · Prescription
PRIMIDONE 50MG · TabletANDA040586-001 · Prescription
PRIMIDONE 250MG · TabletANDA040586-002 · Prescription
PRIMIDONE 250MG · TabletANDA040717-002 · Discontinued
PRIMIDONE 50MG · TabletANDA040717-001 · Discontinued

At a glance

Brand name: Primidone
Route: Oral
Dosage form: Tablet
Applicant: Carnegie
Status: Prescription
FDA approval: 23 Jan 2024
Application: ANDA218366-001

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.

PRIMIDONE 250MG · TabletANDA083551-001 · Prescription

PRIMIDONE 50MG · TabletANDA040667-001 · Discontinued

PRIMIDONE 250MG · TabletANDA040667-002 · Discontinued

PRIMIDONE 50MG · TabletANDA040626-001 · Prescription

PRIMIDONE 250MG · TabletANDA040626-002 · Prescription

PRIMIDONE 50MG · TabletANDA040862-001 · Discontinued

PRIMIDONE 250MG · TabletANDA040862-002 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA218366.

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.