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LIPITOR (nda020702)- (EQ 10MG BASE,EQ 20MG BASE,EQ 40MG BASE,EQ 80MG BASE)

ATORVASTATIN CALCIUM UPJOHN
EQ 10MG BASE,EQ 20MG BASE,EQ 40MG BASE,EQ 80MG BASE
Yes No
2017-Jan-08 Expired
None None
None No
LIPITOR is an HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: • Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors • Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors • Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adult patients with CHD • Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia • Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia • Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) • Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy.
30 0 26
Total Other Developers 33
Drugs with Suitability No
EQ 10MG BASE ** ** Up - 18
EQ 20MG BASE ** ** Up - 18
EQ 40MG BASE ** ** Up - 18
EQ 80MG BASE ** ** - 16 2
NDA Sales Available Total Generic Sales Available
Yes 19
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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