Application Nr Approved Date Route Status External Links
ANDA040663 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Warfarin Sodium Tablets, Usp Are A Vitamin K Antagonist Indicated For: Prophylaxis And Treatment Of Venous Thrombosis And Its Extension, Pulmonary Embolism ( 1 ) Prophylaxis And Treatment Of Thromboembolic Complications Associated With Atrial Fibrillation And/or Cardiac Valve Replacement ( 1 ) Reduction In The Risk Of Death, Recurrent Myocardial Infarction, And Thromboembolic Events Such As Stroke Or Systemic Embolization After Myocardial Infarction ( 1 ) Limitations Of Use Warfarin Sodium Tablets, Usp Have No Direct Effect On An Established Thrombus, Nor Does It Reverse Ischemic Tissue Damage. ( 1 ) Warfarin Sodium Tablets,usp Are Indicated For: Prophylaxis And Treatment Of Venous Thrombosis And Its Extension, Pulmonary Embolism (pe). Prophylaxis And Treatment Of Thromboembolic Complications Associated With Atrial Fibrillation (af) And/or Cardiac Valve Replacement. Reduction In The Risk Of Death, Recurrent Myocardial Infarction (mi), And Thromboembolic Events Such As Stroke Or Systemic Embolization After Myocardial Infarction. Limitations Of Use Warfarin Sodium Tablets, Usp Have No Direct Effect On An Established Thrombus, Nor Does It Reverse Ischemic Tissue Damage. Once A Thrombus Has Occurred, However, The Goals Of Anticoagulant Treatment Are To Prevent Further Extension Of The Formed Clot And To Prevent Secondary Thromboembolic Complications That May Result In Serious And Possibly Fatal Sequelae.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Warfarin Sodium WARFARIN SODIUM ZINC100006264

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