Drug information for SIMCOR

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 1GM;20MG Prescription  (Reference Drug) NIACIN; SIMVASTATIN Simcor ABBOTT 22078
2012-03-30 Review
2012-02-28 Letter
2012-02-28 Label
2012-02-28 Other
2011-06-08 Letter
2011-06-08 Label
2011-05-26 Other Important Information from FDA
2011-03-04 Label
2011-02-28 Letter
2011-02-15 Review
2010-12-28 Letter
2010-08-02 Letter
2010-08-02 Letter
2010-07-31 Label
2010-07-31 Label
2008-08-01 Summary Review
2008-07-31 Review
2008-07-29 Letter
2008-07-29 Label
2008-02-21 Letter
2008-02-20 Label
TABLET, EXTENDED RELEASE; ORAL 1GM;40MG Prescription  (Reference Drug) NIACIN; SIMVASTATIN Simcor ABBOTT   "
TABLET, EXTENDED RELEASE; ORAL 500MG;20MG Prescription  (Reference Drug) NIACIN; SIMVASTATIN Simcor ABBOTT   "
TABLET, EXTENDED RELEASE; ORAL 500MG;40MG Prescription  (Reference Drug) NIACIN; SIMVASTATIN Simcor ABBOTT   "
TABLET, EXTENDED RELEASE; ORAL 750MG;20MG Prescription  (Reference Drug) NIACIN; SIMVASTATIN Simcor ABBOTT   "

Drug Adverse Effects information for SIMCOR

Role code Indications Reaction # Reports
PS ARTHRITIS ARTHRALGIA 1
PS ARTHRITIS DRUG INEFFECTIVE 1
PS ARTHRITIS EAR INFECTION 1
PS ARTHRITIS PSORIATIC ARTHROPATHY 1
PS ARTHRITIS TENDERNESS 1
PS ARTHRITIS TENDON RUPTURE 1
PS BLOOD CHOLESTEROL DYSURIA 1
PS BLOOD CHOLESTEROL HAEMORRHAGE URINARY TRACT 1
PS BLOOD CHOLESTEROL HYPERTENSION 1
PS BLOOD CHOLESTEROL PRURITUS 1
PS BLOOD CHOLESTEROL ABNORMAL HYPOGEUSIA 1
PS BLOOD CHOLESTEROL INCREASED ARTHRALGIA 3
PS BLOOD CHOLESTEROL INCREASED DRUG INEFFECTIVE 3
PS BLOOD CHOLESTEROL INCREASED EAR INFECTION 3
PS BLOOD CHOLESTEROL INCREASED PSORIATIC ARTHROPATHY 3
PS BLOOD CHOLESTEROL INCREASED TENDERNESS 3
PS BLOOD CHOLESTEROL INCREASED TENDON RUPTURE 3
PS BLOOD TRIGLYCERIDES INCREASED BLOOD GLUCOSE INCREASED 1
PS BLOOD TRIGLYCERIDES INCREASED DIABETES MELLITUS 1
PS BLOOD TRIGLYCERIDES INCREASED DISCOMFORT 1
PS BLOOD TRIGLYCERIDES INCREASED ERYTHEMA 1
PS BLOOD TRIGLYCERIDES INCREASED FLUSHING 2
PS BLOOD TRIGLYCERIDES INCREASED INCORRECT DOSE ADMINISTERED 1
PS BLOOD TRIGLYCERIDES INCREASED NEPHROLITHIASIS 1
PS BLOOD TRIGLYCERIDES INCREASED PITUITARY TUMOUR 1
PS BLOOD TRIGLYCERIDES INCREASED STENT PLACEMENT 1
PS GASTROOESOPHAGEAL REFLUX DISEASE ARTHRALGIA 1
PS GASTROOESOPHAGEAL REFLUX DISEASE DRUG INEFFECTIVE 1
PS GASTROOESOPHAGEAL REFLUX DISEASE EAR INFECTION 1
PS GASTROOESOPHAGEAL REFLUX DISEASE PSORIATIC ARTHROPATHY 1
PS GASTROOESOPHAGEAL REFLUX DISEASE TENDERNESS 1
PS GASTROOESOPHAGEAL REFLUX DISEASE TENDON RUPTURE 1
PS GOUT CORONARY ARTERY OCCLUSION 1
PS GOUT FLUSHING 1
PS HIGH DENSITY LIPOPROTEIN DECREASED BLOOD GLUCOSE INCREASED 1
PS HIGH DENSITY LIPOPROTEIN DECREASED CORONARY ARTERY OCCLUSION 1
PS HIGH DENSITY LIPOPROTEIN DECREASED DIABETES MELLITUS 1
PS HIGH DENSITY LIPOPROTEIN DECREASED FLUSHING 2
PS HIGH DENSITY LIPOPROTEIN DECREASED INCORRECT DOSE ADMINISTERED 1
PS HIGH DENSITY LIPOPROTEIN DECREASED STENT PLACEMENT 1
PS HYPERTENSION ARTHRALGIA 1
PS HYPERTENSION DRUG INEFFECTIVE 1
PS HYPERTENSION EAR INFECTION 1
PS HYPERTENSION PSORIATIC ARTHROPATHY 1
PS HYPERTENSION TENDERNESS 1
PS HYPERTENSION TENDON RUPTURE 1
PS HYPOVITAMINOSIS ARTHRALGIA 1
PS HYPOVITAMINOSIS DRUG INEFFECTIVE 1
PS HYPOVITAMINOSIS EAR INFECTION 1
PS HYPOVITAMINOSIS PSORIATIC ARTHROPATHY 1
PS HYPOVITAMINOSIS TENDERNESS 1
PS HYPOVITAMINOSIS TENDON RUPTURE 1
PS LOW DENSITY LIPOPROTEIN INCREASED DISCOMFORT 1
PS LOW DENSITY LIPOPROTEIN INCREASED ERYTHEMA 1
PS LOW DENSITY LIPOPROTEIN INCREASED FLUSHING 1
PS LOW DENSITY LIPOPROTEIN INCREASED PITUITARY TUMOUR 1
PS OSTEOPOROSIS ARTHRALGIA 1
PS OSTEOPOROSIS DRUG INEFFECTIVE 1
PS OSTEOPOROSIS EAR INFECTION 1
PS OSTEOPOROSIS PSORIATIC ARTHROPATHY 1
PS OSTEOPOROSIS TENDERNESS 1
PS OSTEOPOROSIS TENDON RUPTURE 1
PS PAIN ARTHRALGIA 1
PS PAIN DRUG INEFFECTIVE 1
PS PAIN EAR INFECTION 1
PS PAIN PSORIATIC ARTHROPATHY 1
PS PAIN TENDERNESS 1
PS PAIN TENDON RUPTURE 1
PS PRODUCT USED FOR UNKNOWN INDICATION BLOOD GLUCOSE INCREASED 7
PS PRODUCT USED FOR UNKNOWN INDICATION CORONARY ARTERY OCCLUSION 5
PS PRODUCT USED FOR UNKNOWN INDICATION DIABETES MELLITUS 7
PS PRODUCT USED FOR UNKNOWN INDICATION DISCOMFORT 4
PS PRODUCT USED FOR UNKNOWN INDICATION DYSURIA 6
PS PRODUCT USED FOR UNKNOWN INDICATION ERYTHEMA 4
PS PRODUCT USED FOR UNKNOWN INDICATION FLUSHING 16
PS PRODUCT USED FOR UNKNOWN INDICATION HAEMORRHAGE URINARY TRACT 6
PS PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSION 6
PS PRODUCT USED FOR UNKNOWN INDICATION INCORRECT DOSE ADMINISTERED 7
PS PRODUCT USED FOR UNKNOWN INDICATION PITUITARY TUMOUR 4
PS PRODUCT USED FOR UNKNOWN INDICATION PRURITUS 6
PS PRODUCT USED FOR UNKNOWN INDICATION STENT PLACEMENT 7
PS PROPHYLAXIS CORONARY ARTERY OCCLUSION 1
PS PROPHYLAXIS FLUSHING 1
PS PSORIATIC ARTHROPATHY ARTHRALGIA 3
PS PSORIATIC ARTHROPATHY DRUG INEFFECTIVE 3
PS PSORIATIC ARTHROPATHY EAR INFECTION 3
PS PSORIATIC ARTHROPATHY PSORIATIC ARTHROPATHY 3
PS PSORIATIC ARTHROPATHY TENDERNESS 3
PS PSORIATIC ARTHROPATHY TENDON RUPTURE 3
PS STENT PLACEMENT ASTHENIA 1
PS STENT PLACEMENT BACK PAIN 1
PS STENT PLACEMENT MYALGIA 1
SS ARTHRITIS DRUG INEFFECTIVE 1
SS ARTHRITIS EAR INFECTION 1
SS ARTHRITIS PSORIATIC ARTHROPATHY 1
SS ARTHRITIS TENDON RUPTURE 1
SS BLOOD CHOLESTEROL INCREASED DRUG INEFFECTIVE 3
SS BLOOD CHOLESTEROL INCREASED EAR INFECTION 3
SS BLOOD CHOLESTEROL INCREASED PSORIATIC ARTHROPATHY 3
SS BLOOD CHOLESTEROL INCREASED TENDON RUPTURE 3
SS BLOOD TRIGLYCERIDES INCREASED BLOOD GLUCOSE INCREASED 1
SS BLOOD TRIGLYCERIDES INCREASED DIABETES MELLITUS 1
SS BLOOD TRIGLYCERIDES INCREASED DISCOMFORT 1
SS BLOOD TRIGLYCERIDES INCREASED ERYTHEMA 1
SS BLOOD TRIGLYCERIDES INCREASED FLUSHING 2
SS BLOOD TRIGLYCERIDES INCREASED INCORRECT DOSE ADMINISTERED 1
SS BLOOD TRIGLYCERIDES INCREASED PITUITARY TUMOUR 1
SS BLOOD TRIGLYCERIDES INCREASED STENT PLACEMENT 1
SS GASTROOESOPHAGEAL REFLUX DISEASE DRUG INEFFECTIVE 1
SS GASTROOESOPHAGEAL REFLUX DISEASE EAR INFECTION 1
SS GASTROOESOPHAGEAL REFLUX DISEASE PSORIATIC ARTHROPATHY 1
SS GASTROOESOPHAGEAL REFLUX DISEASE TENDON RUPTURE 1
SS HIGH DENSITY LIPOPROTEIN DECREASED BLOOD GLUCOSE INCREASED 1
SS HIGH DENSITY LIPOPROTEIN DECREASED CAROTID ARTERY OCCLUSION 2
SS HIGH DENSITY LIPOPROTEIN DECREASED DIABETES MELLITUS 1
SS HIGH DENSITY LIPOPROTEIN DECREASED ERYTHEMA 2
SS HIGH DENSITY LIPOPROTEIN DECREASED FLUSHING 1
SS HIGH DENSITY LIPOPROTEIN DECREASED INCORRECT DOSE ADMINISTERED 1
SS HIGH DENSITY LIPOPROTEIN DECREASED SKIN BURNING SENSATION 2
SS HIGH DENSITY LIPOPROTEIN DECREASED STENT PLACEMENT 1
SS HYPERTENSION DRUG INEFFECTIVE 1
SS HYPERTENSION EAR INFECTION 1
SS HYPERTENSION PSORIATIC ARTHROPATHY 1
SS HYPERTENSION TENDON RUPTURE 1
SS HYPOVITAMINOSIS DRUG INEFFECTIVE 1
SS HYPOVITAMINOSIS EAR INFECTION 1
SS HYPOVITAMINOSIS PSORIATIC ARTHROPATHY 1
SS HYPOVITAMINOSIS TENDON RUPTURE 1
SS LOW DENSITY LIPOPROTEIN INCREASED DISCOMFORT 1
SS LOW DENSITY LIPOPROTEIN INCREASED ERYTHEMA 1
SS LOW DENSITY LIPOPROTEIN INCREASED FLUSHING 1
SS LOW DENSITY LIPOPROTEIN INCREASED PITUITARY TUMOUR 1
SS OSTEOPOROSIS DRUG INEFFECTIVE 1
SS OSTEOPOROSIS EAR INFECTION 1
SS OSTEOPOROSIS PSORIATIC ARTHROPATHY 1
SS OSTEOPOROSIS TENDON RUPTURE 1
SS PAIN DRUG INEFFECTIVE 1
SS PAIN EAR INFECTION 1
SS PAIN PSORIATIC ARTHROPATHY 1
SS PAIN TENDON RUPTURE 1
SS POLLAKIURIA CAROTID ARTERY OCCLUSION 1
SS POLLAKIURIA ERYTHEMA 1
SS POLLAKIURIA SKIN BURNING SENSATION 1
SS PRODUCT USED FOR UNKNOWN INDICATION BLOOD GLUCOSE INCREASED 7
SS PRODUCT USED FOR UNKNOWN INDICATION BLOOD TRIGLYCERIDES INCREASED 3
SS PRODUCT USED FOR UNKNOWN INDICATION CARDIAC PACEMAKER INSERTION 4
SS PRODUCT USED FOR UNKNOWN INDICATION CAROTID ARTERY OCCLUSION 6
SS PRODUCT USED FOR UNKNOWN INDICATION DIABETES MELLITUS 7
SS PRODUCT USED FOR UNKNOWN INDICATION DISCOMFORT 4
SS PRODUCT USED FOR UNKNOWN INDICATION ERYTHEMA 10
SS PRODUCT USED FOR UNKNOWN INDICATION FLUSHING 11
SS PRODUCT USED FOR UNKNOWN INDICATION IMPLANTABLE DEFIBRILLATOR INSERTION 4
SS PRODUCT USED FOR UNKNOWN INDICATION INCORRECT DOSE ADMINISTERED 7
SS PRODUCT USED FOR UNKNOWN INDICATION PITUITARY TUMOUR 4
SS PRODUCT USED FOR UNKNOWN INDICATION SKIN BURNING SENSATION 6
SS PRODUCT USED FOR UNKNOWN INDICATION STENT PLACEMENT 7
SS PRODUCT USED FOR UNKNOWN INDICATION WEIGHT DECREASED 3
SS PROSTATIC DISORDER CAROTID ARTERY OCCLUSION 1
SS PROSTATIC DISORDER ERYTHEMA 1
SS PROSTATIC DISORDER SKIN BURNING SENSATION 1
SS PSORIATIC ARTHROPATHY DRUG INEFFECTIVE 3
SS PSORIATIC ARTHROPATHY EAR INFECTION 3
SS PSORIATIC ARTHROPATHY PSORIATIC ARTHROPATHY 3
SS PSORIATIC ARTHROPATHY TENDON RUPTURE 3
SS TYPE 2 DIABETES MELLITUS MUSCULAR WEAKNESS 5
SS TYPE 2 DIABETES MELLITUS MYALGIA 5
C ATRIAL FIBRILLATION ANGINA PECTORIS 3
C BENIGN PROSTATIC HYPERPLASIA MEDICATION RESIDUE 1
C BIPOLAR DISORDER GAIT DISTURBANCE 2
C BIPOLAR DISORDER HYPOAESTHESIA 2
C BIPOLAR DISORDER OEDEMA PERIPHERAL 2
C BIPOLAR DISORDER ORAL DISORDER 2
C BLOOD CHOLESTEROL CHEST PAIN 1
C BLOOD CHOLESTEROL UNEVALUABLE EVENT 1
C BLOOD CHOLESTEROL VIRAL PERICARDITIS 1
C CONTRACEPTION ABDOMINAL PAIN 1
C CONTRACEPTION PANCREATITIS 1
C CROHN'S DISEASE CHEST PAIN 2
C CROHN'S DISEASE UNEVALUABLE EVENT 2
C CROHN'S DISEASE VIRAL PERICARDITIS 2
C DEPRESSION ABDOMINAL PAIN 1
C DEPRESSION PANCREATITIS 1
C DIABETES MELLITUS ABDOMINAL PAIN 1
C DIABETES MELLITUS PANCREATITIS 1
C HEAD AND NECK CANCER ATRIAL FIBRILLATION 6
C HEAD AND NECK CANCER EPISTAXIS 6
C HEAD AND NECK CANCER FEBRILE NEUTROPENIA 6
C HEAD AND NECK CANCER UROSEPSIS 6
C LIPIDS ABDOMINAL PAIN 4
C LIPIDS PANCREATITIS 4
C MESOTHELIOMA ANGINA PECTORIS 2
C NEUROPATHY PERIPHERAL GAIT DISTURBANCE 1
C NEUROPATHY PERIPHERAL HYPOAESTHESIA 1
C NEUROPATHY PERIPHERAL OEDEMA PERIPHERAL 1
C NEUROPATHY PERIPHERAL ORAL DISORDER 1
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISCOMFORT 1
C PRODUCT USED FOR UNKNOWN INDICATION CHEST PAIN 1
C PRODUCT USED FOR UNKNOWN INDICATION DYSGEUSIA 1
C PRODUCT USED FOR UNKNOWN INDICATION MALAISE 1
C PRODUCT USED FOR UNKNOWN INDICATION PRODUCT QUALITY ISSUE 1
C PRODUCT USED FOR UNKNOWN INDICATION UNEVALUABLE EVENT 1
C PRODUCT USED FOR UNKNOWN INDICATION VIRAL PERICARDITIS 1
C TYPE 2 DIABETES MELLITUS ABDOMINAL PAIN 1
C TYPE 2 DIABETES MELLITUS FLANK PAIN 1
C TYPE 2 DIABETES MELLITUS PANCREATITIS 2
C TYPE 2 DIABETES MELLITUS PEPTIC ULCER 1
C TYPE 2 DIABETES MELLITUS WEIGHT DECREASED 1
Ads by Google