The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa® Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer).

Dabigatran Etexilate Capsules, are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients, treatment of deep venous thrombosis and pulmonary embolism in adult patients, reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients, prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients following hip replacement surgery. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.