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FLOLIPID (nda206679)- (20MG/5ML,40MG/5ML)

SIMVASTATIN SALERNO PHARMS
20MG/5ML,40MG/5ML
No Yes
2030-Apr-26 Expired
None None
None No
FLOLIPID is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. • Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. • Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. • Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. • Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.
0 0 0
Total Other Developers None
Drugs with Suitability No
20MG/5ML ** ** - - -
40MG/5ML ** ** - - -
NDA Sales Available Total Generic Sales Available
No 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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