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LESCOL (nda020261)- (EQ 20MG BASE,EQ 40MG BASE)

FLUVASTATIN SODIUM NOVARTIS
EQ 20MG BASE,EQ 40MG BASE
Yes No
2012-Jun-12 Expired
None None
None No
LESCOL/ LESCOL XL is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia • Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy • Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD • Slow the progression of atherosclerosis in patients with CHD
2 0 2
Total Other Developers None
Drugs with Suitability No
EQ 20MG BASE ** ** - 2 -
EQ 40MG BASE ** ** - - 2
NDA Sales Available Total Generic Sales Available
No 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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