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Tradename: SIMCOR

Summary for Tradename: SIMCOR

Suppliers: see list2
Formulation / Manufacturing:see details
patent expirations by year for

Pharmacology for Tradename: SIMCOR

Clinical Trials for: SIMCOR

Effect of Simvastatin on Cardiac Function
Status: Completed Condition: Rheumatic Heart Disease; Congenital Heart Disease; Aneurysm; Heart Valve Disease

Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
Status: Recruiting Condition: Congenital Heart Disease; Heart Valve Disease

An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)
Status: Completed Condition: Hyperlipidemia; Mixed Dyslipidemia

Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
Status: Completed Condition: Hypertriglyceridemia

Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
Status: Completed Condition: Hypertriglyceridemia

A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event.
Status: Recruiting Condition: Cardiovascular Diseases

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Feb 15, 2008RXYes6,080,428<disabled><disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Feb 15, 2008RXYes6,129,930<disabled>Y<disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Feb 15, 2008RXYes6,406,715<disabled>Y<disabled>
niacin; simvastatin
TABLET, EXTENDED RELEASE;ORAL022078Feb 15, 2008RXYes6,469,035<disabled><disabled>
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Paragraph IV activity for: SIMCOR

Drugname Dosage Strength RLD Submissiondate
niacin and simvastatinExtended-release Tablets1000 mg/40 mgSimcor2/4/2011
niacin and simvastatinExtended-release Tablets500 mg/40 mgSimcor2/9/2011
niacin and simvastatin (date correction)Extended-release Tablets750 mg/20 mgSimcor2/17/2010
niacin and simvastatinExtended-release Tablets750 mg/20 mgSimcor3/1/2010
niacin and simvastatinExtended-release Tablets500 mg/20 mgSimcor2/12/2010
niacin and simvastatinExtended-release Tablets750 mg/20 mgSimcor2/12/2010
niacin and simvastatinExtended-release Tablets500 mg/20 mgSimcor3/19/2010
niacin andsimvastatinExtended-release Tablets1000 mg/20 mgSimcor9/17/2009

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