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ZETIA (nda021445)- (10MG)

EZETIMIBE ORGANON
10MG
Yes No
2026-Apr-30 Expired
None None
None No
ZETIA is an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to: • Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) • Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate • Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin • Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia).
14 0 14
Total Other Developers 12
Drugs with Suitability No
10MG ** ** Up - 11
NDA Sales Available Total Generic Sales Available
Yes 12
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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