Drug information for FAZACLO ODT

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, ORALLY DISINTEGRATING; ORAL 100MG Prescription  (Reference Drug) CLOZAPINE Clozapine AZUR PHARMA INTL 21590
2012-01-12 Letter

2012-01-09 Label

2010-12-06 Letter

2010-12-04 Label

2010-09-13 Letter

2010-09-10 Label

2010-07-14 Letter

2010-07-14 Letter

2010-07-12 Label

2010-07-12 Label

2008-08-19 Letter

2008-07-17 Letter

2007-06-04 Label

2007-06-04 Letter

2006-02-22 Label

2006-02-22 Letter

2005-10-06 Review

2005-08-16 Letter

2005-08-15 Label

2005-08-15 Letter

2005-06-10 Letter

2005-06-10 Label

2004-09-07 Letter

2004-06-23 Letter

2004-03-03 Label

2004-02-27 Letter
TABLET, ORALLY DISINTEGRATING; ORAL 12.5MG Prescription   CLOZAPINE Clozapine AZUR PHARMA INTL   "
TABLET, ORALLY DISINTEGRATING; ORAL 150MG Prescription   CLOZAPINE Clozapine AZUR PHARMA INTL   "
TABLET, ORALLY DISINTEGRATING; ORAL 200MG Prescription   CLOZAPINE Clozapine AZUR PHARMA INTL   "
TABLET, ORALLY DISINTEGRATING; ORAL 25MG Prescription   CLOZAPINE Clozapine AZUR PHARMA INTL   "
TABLET, ORALLY DISINTEGRATING; ORAL 50MG Discontinued   CLOZAPINE Clozapine AZUR PHARMA INTL   "

Drug Adverse Effects information for FAZACLO ODT

Role code Indications Reaction # Reports
PS ATTENTION DEFICIT/HYPERACTIVITY DISORDER CHRONIC HEPATIC FAILURE 1
PS BIPOLAR I DISORDER CACHEXIA 1
PS BIPOLAR I DISORDER FAILURE TO THRIVE 1
PS DEMENTIA ACUTE RESPIRATORY FAILURE 1
PS DEMENTIA CARDIAC FAILURE CONGESTIVE 1
PS DEMENTIA PNEUMONITIS 1
PS DEMENTIA RENAL FAILURE ACUTE 1
PS MANIA DROWNING 1
PS PSYCHOTIC DISORDER CHRONIC HEPATIC FAILURE 1
PS SCHIZOAFFECTIVE DISORDER CEREBRAL HAEMORRHAGE 1
PS SCHIZOAFFECTIVE DISORDER ESSENTIAL HYPERTENSION 1
PS SCHIZOAFFECTIVE DISORDER FALL 1
PS SCHIZOPHRENIA ABNORMAL BEHAVIOUR 1
PS SCHIZOPHRENIA ARTERIOSCLEROSIS 1
PS SCHIZOPHRENIA CARDIAC ARREST 1
PS SCHIZOPHRENIA ESSENTIAL HYPERTENSION 1
PS SCHIZOPHRENIA HYPERLIPIDAEMIA 1
PS SCHIZOPHRENIA MENTAL DISORDER 1
PS SCHIZOPHRENIA MYOCARDIAL INFARCTION 1
PS SCHIZOPHRENIA RENAL FAILURE 1
PS SCHIZOPHRENIA, PARANOID TYPE ABNORMAL BEHAVIOUR 1
PS SCHIZOPHRENIA, PARANOID TYPE CHRONIC HEPATIC FAILURE 1
PS SCHIZOPHRENIA, PARANOID TYPE LUNG NEOPLASM MALIGNANT 1
PS SCHIZOPHRENIA, PARANOID TYPE MENTAL DISORDER 1
PS SCHIZOPHRENIA, PARANOID TYPE METASTASIS 1
PS SCHIZOPHRENIA, PARANOID TYPE RESPIRATORY FAILURE 1
PS SCHIZOPHRENIA, PARANOID TYPE SCHIZOPHRENIA 1
PS SCHIZOPHRENIA, PARANOID TYPE THROAT CANCER 1
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