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VYTORIN (nda021687)- (10MG;10MG,10MG;20MG,10MG;40MG,10MG;80MG)

EZETIMIBE; SIMVASTATIN ORGANON
10MG;10MG,10MG;20MG,10MG;40MG,10MG;80MG
Yes No
2024-Jun-11 Expired
None None
None No
VYTORIN, which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to: • reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. • reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments.
6 0 6
Total Other Developers 2
Drugs with Suitability No
10MG;10MG ** ** - 5 -
10MG;20MG ** ** - - 5
10MG;40MG ** ** Up 5 -
10MG;80MG ** ** - - 5
NDA Sales Available Total Generic Sales Available
Yes 5
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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