Vitamin K antagonists

Coumadin

Approved 8 Jun 1954OralTablet

The FDA lists this product in 12 strengths and forms.

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Composition

Active ingredients: WARFARIN SODIUM 4MG

Strengths and forms

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NDA009218-012 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application NDA009218.

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At a glance

Brand name: Coumadin
Active substance: warfarin sodium
Drug class: Vitamin K antagonists
Group: Anticoagulants and antiplatelets
Route: Oral
Dosage form: Tablet
Applicant: Bristol Myers Squibb
Status: Discontinued
FDA approval: 8 Jun 1954
Application: NDA009218-023
RxCUI: 202421

Guidelines

FDA 2025

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