Drug information for RAZADYNE ER

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE, EXTENDED RELEASE; ORAL EQ 16MG BASE Prescription AB  GALANTAMINE HYDROBROMIDE Galantamine JANSSEN PHARMS 21615
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

2005-12-05 Review

2005-07-29 Other Important Information from FDA

2005-05-03 Letter

2004-12-29 Letter

2004-12-29 Label
CAPSULE, EXTENDED RELEASE; ORAL EQ 24MG BASE Prescription AB  GALANTAMINE HYDROBROMIDE Galantamine JANSSEN PHARMS   "
CAPSULE, EXTENDED RELEASE; ORAL EQ 8MG BASE Prescription AB (Reference Drug) GALANTAMINE HYDROBROMIDE Galantamine JANSSEN PHARMS   "

Drug Adverse Effects information for RAZADYNE ER

Role code Indications Reaction # Reports
PS DEPRESSION ATTENTION DEFICIT/HYPERACTIVITY DISORDER 4
PS DEPRESSION DEPRESSION 4
PS DEPRESSION HYPERHIDROSIS 4
PS DEPRESSION THERAPY CESSATION 4
PS HEAD INJURY ATTENTION DEFICIT/HYPERACTIVITY DISORDER 4
PS HEAD INJURY DEPRESSION 4
PS HEAD INJURY HYPERHIDROSIS 4
PS HEAD INJURY THERAPY CESSATION 4
C ARTHRALGIA ACTIVITIES OF DAILY LIVING IMPAIRED 1
C ARTHRALGIA AMNESIA 1
C ARTHRALGIA ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C ARTHRALGIA CEREBRAL ATROPHY 1
C ARTHRALGIA COMA 1
C ARTHRALGIA CRANIOCEREBRAL INJURY 1
C ARTHRALGIA DEPRESSION 1
C ARTHRALGIA FEELING ABNORMAL 1
C ARTHRALGIA HYPERHIDROSIS 1
C ARTHRALGIA PAIN 1
C ARTHRALGIA PRODUCT QUALITY ISSUE 1
C ARTHRALGIA ROAD TRAFFIC ACCIDENT 1
C ARTHRALGIA ROTATOR CUFF SYNDROME 1
C ARTHRALGIA SPINAL COLUMN INJURY 1
C ASTHMA ACTIVITIES OF DAILY LIVING IMPAIRED 1
C ASTHMA AMNESIA 1
C ASTHMA ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C ASTHMA CEREBRAL ATROPHY 1
C ASTHMA COMA 1
C ASTHMA CRANIOCEREBRAL INJURY 1
C ASTHMA DEPRESSION 1
C ASTHMA FEELING ABNORMAL 1
C ASTHMA HYPERHIDROSIS 1
C ASTHMA PAIN 1
C ASTHMA PRODUCT QUALITY ISSUE 1
C ASTHMA ROAD TRAFFIC ACCIDENT 1
C ASTHMA ROTATOR CUFF SYNDROME 1
C ASTHMA SPINAL COLUMN INJURY 1
C BREAKTHROUGH PAIN ACTIVITIES OF DAILY LIVING IMPAIRED 1
C BREAKTHROUGH PAIN AMNESIA 1
C BREAKTHROUGH PAIN ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C BREAKTHROUGH PAIN CEREBRAL ATROPHY 1
C BREAKTHROUGH PAIN COMA 1
C BREAKTHROUGH PAIN CRANIOCEREBRAL INJURY 1
C BREAKTHROUGH PAIN DEPRESSION 1
C BREAKTHROUGH PAIN FEELING ABNORMAL 1
C BREAKTHROUGH PAIN HYPERHIDROSIS 1
C BREAKTHROUGH PAIN PAIN 1
C BREAKTHROUGH PAIN PRODUCT QUALITY ISSUE 1
C BREAKTHROUGH PAIN ROAD TRAFFIC ACCIDENT 1
C BREAKTHROUGH PAIN ROTATOR CUFF SYNDROME 1
C BREAKTHROUGH PAIN SPINAL COLUMN INJURY 1
C CRANIOCEREBRAL INJURY ACTIVITIES OF DAILY LIVING IMPAIRED 1
C CRANIOCEREBRAL INJURY AMNESIA 1
C CRANIOCEREBRAL INJURY ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C CRANIOCEREBRAL INJURY CEREBRAL ATROPHY 1
C CRANIOCEREBRAL INJURY COMA 1
C CRANIOCEREBRAL INJURY CRANIOCEREBRAL INJURY 1
C CRANIOCEREBRAL INJURY DEPRESSION 1
C CRANIOCEREBRAL INJURY FEELING ABNORMAL 1
C CRANIOCEREBRAL INJURY HYPERHIDROSIS 1
C CRANIOCEREBRAL INJURY PAIN 1
C CRANIOCEREBRAL INJURY PRODUCT QUALITY ISSUE 1
C CRANIOCEREBRAL INJURY ROAD TRAFFIC ACCIDENT 1
C CRANIOCEREBRAL INJURY ROTATOR CUFF SYNDROME 1
C CRANIOCEREBRAL INJURY SPINAL COLUMN INJURY 1
C HEAD INJURY ACTIVITIES OF DAILY LIVING IMPAIRED 1
C HEAD INJURY AMNESIA 1
C HEAD INJURY ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C HEAD INJURY CEREBRAL ATROPHY 1
C HEAD INJURY COMA 1
C HEAD INJURY CRANIOCEREBRAL INJURY 1
C HEAD INJURY DEPRESSION 1
C HEAD INJURY FEELING ABNORMAL 1
C HEAD INJURY HYPERHIDROSIS 1
C HEAD INJURY PAIN 1
C HEAD INJURY PRODUCT QUALITY ISSUE 1
C HEAD INJURY ROAD TRAFFIC ACCIDENT 1
C HEAD INJURY ROTATOR CUFF SYNDROME 1
C HEAD INJURY SPINAL COLUMN INJURY 1
C PAIN ACTIVITIES OF DAILY LIVING IMPAIRED 1
C PAIN AMNESIA 1
C PAIN ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C PAIN CEREBRAL ATROPHY 1
C PAIN COMA 1
C PAIN CRANIOCEREBRAL INJURY 1
C PAIN DEPRESSION 1
C PAIN FEELING ABNORMAL 1
C PAIN HYPERHIDROSIS 1
C PAIN PAIN 1
C PAIN PRODUCT QUALITY ISSUE 1
C PAIN ROAD TRAFFIC ACCIDENT 1
C PAIN ROTATOR CUFF SYNDROME 1
C PAIN SPINAL COLUMN INJURY 1
C PAIN IN EXTREMITY ACTIVITIES OF DAILY LIVING IMPAIRED 1
C PAIN IN EXTREMITY AMNESIA 1
C PAIN IN EXTREMITY ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C PAIN IN EXTREMITY CEREBRAL ATROPHY 1
C PAIN IN EXTREMITY COMA 1
C PAIN IN EXTREMITY CRANIOCEREBRAL INJURY 1
C PAIN IN EXTREMITY DEPRESSION 1
C PAIN IN EXTREMITY FEELING ABNORMAL 1
C PAIN IN EXTREMITY HYPERHIDROSIS 1
C PAIN IN EXTREMITY PAIN 1
C PAIN IN EXTREMITY PRODUCT QUALITY ISSUE 1
C PAIN IN EXTREMITY ROAD TRAFFIC ACCIDENT 1
C PAIN IN EXTREMITY ROTATOR CUFF SYNDROME 1
C PAIN IN EXTREMITY SPINAL COLUMN INJURY 1
C PRODUCT USED FOR UNKNOWN INDICATION ACTIVITIES OF DAILY LIVING IMPAIRED 1
C PRODUCT USED FOR UNKNOWN INDICATION AMNESIA 1
C PRODUCT USED FOR UNKNOWN INDICATION ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C PRODUCT USED FOR UNKNOWN INDICATION CEREBRAL ATROPHY 1
C PRODUCT USED FOR UNKNOWN INDICATION COMA 1
C PRODUCT USED FOR UNKNOWN INDICATION CRANIOCEREBRAL INJURY 1
C PRODUCT USED FOR UNKNOWN INDICATION DEPRESSION 1
C PRODUCT USED FOR UNKNOWN INDICATION FEELING ABNORMAL 1
C PRODUCT USED FOR UNKNOWN INDICATION HYPERHIDROSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 1
C PRODUCT USED FOR UNKNOWN INDICATION PRODUCT QUALITY ISSUE 1
C PRODUCT USED FOR UNKNOWN INDICATION ROAD TRAFFIC ACCIDENT 1
C PRODUCT USED FOR UNKNOWN INDICATION ROTATOR CUFF SYNDROME 1
C PRODUCT USED FOR UNKNOWN INDICATION SPINAL COLUMN INJURY 1
C SLEEP DISORDER ACTIVITIES OF DAILY LIVING IMPAIRED 1
C SLEEP DISORDER AMNESIA 1
C SLEEP DISORDER ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
C SLEEP DISORDER CEREBRAL ATROPHY 1
C SLEEP DISORDER COMA 1
C SLEEP DISORDER CRANIOCEREBRAL INJURY 1
C SLEEP DISORDER DEPRESSION 1
C SLEEP DISORDER FEELING ABNORMAL 1
C SLEEP DISORDER HYPERHIDROSIS 1
C SLEEP DISORDER PAIN 1
C SLEEP DISORDER PRODUCT QUALITY ISSUE 1
C SLEEP DISORDER ROAD TRAFFIC ACCIDENT 1
C SLEEP DISORDER ROTATOR CUFF SYNDROME 1
C SLEEP DISORDER SPINAL COLUMN INJURY 1
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