Drug information for RAZADYNE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
SOLUTION; ORAL
4MG/ML
Prescription
AA (Reference Drug)
GALANTAMINE HYDROBROMIDE
Galantamine
JANSSEN PHARMS
21224
2012-05-01 Label
2012-03-06 Label
2012-03-06 Label
2012-03-05 Letter
2012-03-05 Letter
2012-03-05 Letter
2006-05-01 Letter
2006-05-01 Letter
2006-05-01 Letter
2006-05-01 Letter
2005-07-29 Other Important Information from FDA
2005-05-03 Letter
2003-09-09 Letter
2002-05-02 Letter
2002-03-05 Review
2001-06-22 Letter
2001-06-22 Label
TABLET; ORAL
EQ 12MG BASE
Prescription
AB
GALANTAMINE HYDROBROMIDE
Galantamine
JANSSEN PHARMS
21169
2012-05-01 Label
2012-03-06 Label
2012-03-06 Label
2012-03-05 Letter
2012-03-05 Letter
2012-03-05 Letter
2006-05-01 Letter
2006-05-01 Letter
2006-05-01 Letter
2006-05-01 Letter
2005-07-29 Other Important Information from FDA
2005-05-03 Letter
2003-09-09 Letter
2002-05-02 Letter
2001-12-18 Review
2001-02-28 Letter
2001-02-28 Label
TABLET; ORAL
EQ 4MG BASE
Prescription
AB (Reference Drug)
GALANTAMINE HYDROBROMIDE
Galantamine
JANSSEN PHARMS
"
TABLET; ORAL
EQ 8MG BASE
Prescription
AB
GALANTAMINE HYDROBROMIDE
Galantamine
JANSSEN PHARMS
"
Drug Adverse Effects information for RAZADYNE
Role code
Indications
Reaction
# Reports
PS
DEMENTIA
DYSKINESIA
1
PS
DEMENTIA
TREMOR
1
PS
DIABETES MELLITUS
DYSKINESIA
2
PS
DIABETES MELLITUS
TREMOR
2
PS
NUTRITIONAL SUPPORT
DYSKINESIA
1
PS
NUTRITIONAL SUPPORT
TREMOR
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DYSKINESIA
4
PS
PRODUCT USED FOR UNKNOWN INDICATION
TREMOR
4
C
AGE-RELATED MACULAR DEGENERATION
CEREBROVASCULAR ACCIDENT
2
C
AGE-RELATED MACULAR DEGENERATION
HEMIANOPIA HOMONYMOUS
2
C
AGE-RELATED MACULAR DEGENERATION
HEMIPLEGIA
2
C
AGE-RELATED MACULAR DEGENERATION
NEUROLOGIC NEGLECT SYNDROME
2
C
ARTERIOSCLEROSIS CORONARY ARTERY
CEREBROVASCULAR ACCIDENT
1
C
ARTERIOSCLEROSIS CORONARY ARTERY
HEMIANOPIA HOMONYMOUS
1
C
ARTERIOSCLEROSIS CORONARY ARTERY
HEMIPLEGIA
1
C
ARTERIOSCLEROSIS CORONARY ARTERY
NEUROLOGIC NEGLECT SYNDROME
1
C
ATRIAL FIBRILLATION
CEREBROVASCULAR ACCIDENT
1
C
ATRIAL FIBRILLATION
HEMIANOPIA HOMONYMOUS
1
C
ATRIAL FIBRILLATION
HEMIPLEGIA
1
C
ATRIAL FIBRILLATION
NEUROLOGIC NEGLECT SYNDROME
1
C
CARDIOVASCULAR EVENT PROPHYLAXIS
CEREBROVASCULAR ACCIDENT
2
C
CARDIOVASCULAR EVENT PROPHYLAXIS
HEMIANOPIA HOMONYMOUS
2
C
CARDIOVASCULAR EVENT PROPHYLAXIS
HEMIPLEGIA
2
C
CARDIOVASCULAR EVENT PROPHYLAXIS
NEUROLOGIC NEGLECT SYNDROME
2
C
CHEST PAIN
CEREBROVASCULAR ACCIDENT
1
C
CHEST PAIN
HEMIANOPIA HOMONYMOUS
1
C
CHEST PAIN
HEMIPLEGIA
1
C
CHEST PAIN
NEUROLOGIC NEGLECT SYNDROME
1
C
DEMENTIA ALZHEIMER'S TYPE
CEREBROVASCULAR ACCIDENT
1
C
DEMENTIA ALZHEIMER'S TYPE
HEMIANOPIA HOMONYMOUS
1
C
DEMENTIA ALZHEIMER'S TYPE
HEMIPLEGIA
1
C
DEMENTIA ALZHEIMER'S TYPE
NEUROLOGIC NEGLECT SYNDROME
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
CEREBROVASCULAR ACCIDENT
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
HEMIANOPIA HOMONYMOUS
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
HEMIPLEGIA
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
NEUROLOGIC NEGLECT SYNDROME
2
C
HYPERLIPIDAEMIA
CEREBROVASCULAR ACCIDENT
1
C
HYPERLIPIDAEMIA
HEMIANOPIA HOMONYMOUS
1
C
HYPERLIPIDAEMIA
HEMIPLEGIA
1
C
HYPERLIPIDAEMIA
NEUROLOGIC NEGLECT SYNDROME
1
C
HYPERTENSION
CEREBROVASCULAR ACCIDENT
1
C
HYPERTENSION
HEMIANOPIA HOMONYMOUS
1
C
HYPERTENSION
HEMIPLEGIA
1
C
HYPERTENSION
NEUROLOGIC NEGLECT SYNDROME
1
C
MULTIPLE SCLEROSIS
FEELING ABNORMAL
2
C
MULTIPLE SCLEROSIS
GASTRIC DISORDER
2
C
MULTIPLE SCLEROSIS
INCONTINENCE
2
C
MULTIPLE SCLEROSIS
INTESTINAL OBSTRUCTION
2
C
MULTIPLE SCLEROSIS
OVERDOSE
2
C
MULTIPLE SCLEROSIS
PAIN
1
C
MULTIPLE SCLEROSIS
PAIN OF SKIN
2
C
MULTIPLE SCLEROSIS
SPINAL NERVE STIMULATOR IMPLANTATION
2
C
MUSCLE SPASMS
FEELING ABNORMAL
1
C
MUSCLE SPASMS
GASTRIC DISORDER
1
C
MUSCLE SPASMS
INCONTINENCE
1
C
MUSCLE SPASMS
INTESTINAL OBSTRUCTION
1
C
MUSCLE SPASMS
OVERDOSE
1
C
MUSCLE SPASMS
PAIN
1
C
MUSCLE SPASMS
PAIN OF SKIN
1
C
MUSCLE SPASMS
SPINAL NERVE STIMULATOR IMPLANTATION
1
C
OSTEOPOROSIS
CEREBROVASCULAR ACCIDENT
1
C
OSTEOPOROSIS
HEMIANOPIA HOMONYMOUS
1
C
OSTEOPOROSIS
HEMIPLEGIA
1
C
OSTEOPOROSIS
NEUROLOGIC NEGLECT SYNDROME
1
C
OSTEOPOROSIS PROPHYLAXIS
CEREBROVASCULAR ACCIDENT
1
C
OSTEOPOROSIS PROPHYLAXIS
HEMIANOPIA HOMONYMOUS
1
C
OSTEOPOROSIS PROPHYLAXIS
HEMIPLEGIA
1
C
OSTEOPOROSIS PROPHYLAXIS
NEUROLOGIC NEGLECT SYNDROME
1
C
PAIN
AGGRESSION
1
C
PAIN
AGITATION
1
C
PAIN
DEMENTIA
1
C
PAIN
IMPAIRED SELF-CARE
1
C
PAIN
RESTLESSNESS
1
C
PRURITUS
FEELING ABNORMAL
1
C
PRURITUS
GASTRIC DISORDER
1
C
PRURITUS
INCONTINENCE
1
C
PRURITUS
INTESTINAL OBSTRUCTION
1
C
PRURITUS
OVERDOSE
1
C
PRURITUS
PAIN
1
C
PRURITUS
PAIN OF SKIN
1
C
PRURITUS
SPINAL NERVE STIMULATOR IMPLANTATION
1
C
SUPPLEMENTATION THERAPY
CEREBROVASCULAR ACCIDENT
1
C
SUPPLEMENTATION THERAPY
HEMIANOPIA HOMONYMOUS
1
C
SUPPLEMENTATION THERAPY
HEMIPLEGIA
1
C
SUPPLEMENTATION THERAPY
NEUROLOGIC NEGLECT SYNDROME
1
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