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
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