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PRAVACHOL (nda019898)- (10MG,20MG,40MG,80MG)

PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB
10MG,20MG,40MG,80MG
Yes No
2014-Oct-22 Expired
None None
None No
PRAVACHOL is an HMG-CoA reductase inhibitor (statin) indicated: • To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). • To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. • As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. • As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.
13 1 11
Total Other Developers None
Drugs with Suitability No
10MG ** ** - - 6
20MG ** ** - - 5
40MG ** ** - - 6
80MG ** ** - - 5
NDA Sales Available Total Generic Sales Available
No 10
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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