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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