Application Nr Approved Date Route Status External Links
ANDA040616 2006-07-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Warfarin Sodium Tablets 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 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. Warfarin Sodium Tablets 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 Have No Direct Effect On An Established Thrombus, Nor Does It Reverse Ischemic Tissue Damage. (1)

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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