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LIVALO (nda022363)- (EQ 1MG BASE,EQ 2MG BASE,EQ 4MG BASE)

PITAVASTATIN CALCIUM KOWA CO
EQ 1MG BASE,EQ 2MG BASE,EQ 4MG BASE
Yes No
2024-Aug-19 2014-Aug-03
None None
None No
LIVALO is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet in: • Adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). • Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.
7 0 6
Total Other Developers 2
Drugs with Suitability No
EQ 1MG BASE ** ** Up - 5
EQ 2MG BASE ** ** Up - 5
EQ 4MG BASE ** ** Down - 5
NDA Sales Available Total Generic Sales Available
Yes 4
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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