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FLOLAN (nda020444)- (EQ 0.5MG BASE/VIAL,EQ 1.5MG BASE/VIAL)

EPOPROSTENOL SODIUM GLAXOSMITHKLINE LLC
EQ 0.5MG BASE/VIAL,EQ 1.5MG BASE/VIAL
No No
2006-May-12 Expired
None None
None No
FLOLAN is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Studies establishing effectiveness included predominantly (97%) patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (49%) or PAH associated with connective tissue diseases (51%).
1 0 1
Total Other Developers 1
Drugs with Suitability No
EQ 0.5MG BASE/VIAL ** ** - - -
EQ 1.5MG BASE/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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