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XARELTO (nda022406)- (2.5MG,10MG,15MG,20MG)

RIVAROXABAN JANSSEN PHARMS
2.5MG,10MG,15MG,20MG
Yes No
2034-Aug-17 2016-Jul-01
None None
None No
XARELTO is a factor Xa inhibitor indicated:  to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation  for treatment of deep vein thrombosis (DVT)  for treatment of pulmonary embolism (PE)  for reduction in the risk of recurrence of DVT or PE  for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery  for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients  to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD)  to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD  for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years  for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure
0 11 0
Total Other Developers 40
Drugs with Suitability No
2.5MG ** ** Up - -
10MG ** ** Up - -
15MG ** ** Up - -
20MG ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
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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