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PRADAXA (nda022512)- (EQ 75MG BASE,EQ 150MG BASE,EQ 110MG BASE)

DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM
EQ 75MG BASE,EQ 150MG BASE,EQ 110MG BASE
Yes No
2031-Jul-20 2015-Oct-19
None None
None No
PRADAXA Capsules is a direct thrombin inhibitor indicated: • To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days • To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated • For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery • For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days • To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated
5 6 5
Total Other Developers 20
Drugs with Suitability No
EQ 75MG BASE ** ** Down - 5
EQ 150MG BASE ** ** Down - 5
EQ 110MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 3
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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