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JUVISYNC (nda202343)- (10MG;EQ 100MG BASE,10MG;EQ 50MG BASE,20MG;EQ 100MG BASE,20MG;EQ 50MG BASE,40MG;EQ 100MG BASE,40MG;EQ 50MG BASE)

SIMVASTATIN; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME
10MG;EQ 100MG BASE,10MG;EQ 50MG BASE,20MG;EQ 100MG BASE,20MG;EQ 50MG BASE,40MG;EQ 100MG BASE,40MG;EQ 50MG BASE
Yes No
2026-Oct-11 Expired
None None
None No
JUVISYNC is combination drug of: Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Simvastatin is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:  Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events.  Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.  Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia.  Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia.
0 0 0
Total Other Developers None
Drugs with Suitability No
10MG;EQ 100MG BASE ** ** - - -
10MG;EQ 50MG BASE ** ** - - -
20MG;EQ 100MG BASE ** ** - - -
20MG;EQ 50MG BASE ** ** - - -
40MG;EQ 100MG BASE ** ** - - -
40MG;EQ 50MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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