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ZOCOR (nda019766)- (5MG,10MG,20MG,40MG,80MG)

SIMVASTATIN ORGANON
5MG,10MG,20MG,40MG,80MG
Yes No
2009-Nov-26 Expired
None None
None No
ZOCOR is an HMG-CoA reductase inhibitor indicated: • To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.
11 1 8
Total Other Developers 3
Drugs with Suitability No
5MG ** ** - - 4
10MG ** ** - - 6
20MG ** ** - - 6
40MG ** ** - - 6
80MG ** ** - - 6
NDA Sales Available Total Generic Sales Available
No 5
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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