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ARIXTRA (nda021345)- (2.5MG/0.5ML,5MG/0.4ML,7.5MG/0.6ML,10MG/0.8ML)

FONDAPARINUX SODIUM MYLAN IRELAND LTD
2.5MG/0.5ML,5MG/0.4ML,7.5MG/0.6ML,10MG/0.8ML
No No
2003-Aug-19 Expired
None None
None No
ARIXTRA is a Factor Xa inhibitor (anticoagulant) indicated for: • Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. • Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin.
4 0 4
Total Other Developers 1
Drugs with Suitability No
2.5MG/0.5ML ** ** - - 4
5MG/0.4ML ** ** - - -
7.5MG/0.6ML ** ** - - 4
10MG/0.8ML ** ** - - 4
NDA Sales Available Total Generic Sales Available
Yes 4
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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