Drug information for ELOXATIN

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; IV (INFUSION) 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Discontinued   OXALIPLATIN oxaliplatin SANOFI AVENTIS US 21492
2012-01-03 Letter
2011-12-28 Label
2009-03-26 Label
2009-03-17 Letter
2008-05-28 Letter
2007-01-16 Label
2007-01-16 Letter
2006-03-24 Review
2006-03-14 Label
2006-03-14 Letter
2004-11-08 Letter
2004-11-08 Letter
2004-11-05 Label
2004-11-05 Label
2004-06-03 Letter
2004-01-15 Label
2004-01-12 Letter
2003-04-22 Other Important Information from FDA
2002-08-09 Letter
2002-08-09 Label
2002-08-09 Review
INJECTABLE; IV (INFUSION) 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Discontinued   OXALIPLATIN oxaliplatin SANOFI AVENTIS US   "
INJECTABLE; IV (INFUSION) 100MG/20ML (5MG/ML) Prescription AP (Reference Drug) OXALIPLATIN oxaliplatin SANOFI AVENTIS US 21759
2012-01-03 Letter
2011-12-28 Label
2009-03-26 Label
2009-03-17 Letter
2008-05-28 Letter
2007-07-02 Review
2006-03-14 Label
2006-03-14 Letter
2005-02-03 Letter
2005-02-03 Label
INJECTABLE; IV (INFUSION) 200MG/40ML (5MG/ML) Prescription  (Reference Drug) OXALIPLATIN oxaliplatin SANOFI AVENTIS US   "
INJECTABLE; IV (INFUSION) 50MG/10ML (5MG/ML) Prescription AP (Reference Drug) OXALIPLATIN oxaliplatin SANOFI AVENTIS US   "

Drug Adverse Effects information for ELOXATIN

Role code Indications Reaction # Reports
PS BILE DUCT CANCER DRUG INEFFECTIVE 1
PS BILE DUCT CANCER HICCUPS 1
PS BILE DUCT CANCER HYPERSENSITIVITY 1
PS BILE DUCT CANCER NEUROPATHY PERIPHERAL 1
PS BILE DUCT CANCER TRISMUS 1
PS COLON CANCER ABDOMINAL PAIN 1
PS COLON CANCER ALTERED STATE OF CONSCIOUSNESS 2
PS COLON CANCER CARDIAC FAILURE 2
PS COLON CANCER CHEST PAIN 2
PS COLON CANCER DISEASE PROGRESSION 1
PS COLON CANCER DYSPNOEA 2
PS COLON CANCER HYPERHIDROSIS 2
PS COLON CANCER MULTIFOCAL MOTOR NEUROPATHY 3
PS COLON CANCER RENAL FAILURE ACUTE 2
PS COLON CANCER VITAL FUNCTIONS ABNORMAL 2
PS COLORECTAL CANCER ABDOMINAL PAIN 1
PS COLORECTAL CANCER CARDIOGENIC SHOCK 2
PS COLORECTAL CANCER CHEST PAIN 2
PS COLORECTAL CANCER CYANOSIS 1
PS COLORECTAL CANCER EXTRAVASATION 2
PS COLORECTAL CANCER GUILLAIN-BARRE SYNDROME 1
PS COLORECTAL CANCER HYPOTENSION 2
PS COLORECTAL CANCER SKIN INDURATION 2
PS ENTERITIS DECREASED APPETITE 1
PS ENTERITIS DEHYDRATION 1
PS ENTERITIS DEVICE RELATED INFECTION 1
PS ENTERITIS DIARRHOEA 1
PS ENTERITIS GASTRITIS EROSIVE 1
PS ENTERITIS GASTROOESOPHAGEAL REFLUX DISEASE 1
PS ENTERITIS LOWER GASTROINTESTINAL HAEMORRHAGE 1
PS ENTERITIS VOMITING 1
PS GASTRIC CANCER PAIN 3
PS GASTRIC CANCER RESPIRATORY DISTRESS 3
PS GASTROINTESTINAL INFLAMMATION DECREASED APPETITE 1
PS GASTROINTESTINAL INFLAMMATION DEHYDRATION 1
PS GASTROINTESTINAL INFLAMMATION DEVICE RELATED INFECTION 1
PS GASTROINTESTINAL INFLAMMATION DIARRHOEA 1
PS GASTROINTESTINAL INFLAMMATION GASTRITIS EROSIVE 1
PS GASTROINTESTINAL INFLAMMATION GASTROOESOPHAGEAL REFLUX DISEASE 1
PS GASTROINTESTINAL INFLAMMATION LOWER GASTROINTESTINAL HAEMORRHAGE 1
PS GASTROINTESTINAL INFLAMMATION VOMITING 1
PS INSOMNIA CONSTIPATION 1
PS INSOMNIA DYSGRAPHIA 1
PS INSOMNIA DYSPNOEA 1
PS INSOMNIA FEELING COLD 1
PS INSOMNIA GAIT DISTURBANCE 1
PS INSOMNIA HEPATIC NEOPLASM MALIGNANT RESECTABLE 1
PS INSOMNIA HYPOAESTHESIA 1
PS INSOMNIA NEUROPATHY PERIPHERAL 1
PS INSOMNIA PARAESTHESIA 1
PS MALNUTRITION DECREASED APPETITE 3
PS MALNUTRITION DEHYDRATION 3
PS MALNUTRITION DEVICE RELATED INFECTION 3
PS MALNUTRITION DIARRHOEA 3
PS MALNUTRITION GASTRITIS EROSIVE 3
PS MALNUTRITION GASTROOESOPHAGEAL REFLUX DISEASE 3
PS MALNUTRITION LOWER GASTROINTESTINAL HAEMORRHAGE 3
PS MALNUTRITION VOMITING 3
PS NAUSEA DECREASED APPETITE 1
PS NAUSEA DEHYDRATION 1
PS NAUSEA DEVICE RELATED INFECTION 1
PS NAUSEA DIARRHOEA 1
PS NAUSEA GASTRITIS EROSIVE 1
PS NAUSEA GASTROOESOPHAGEAL REFLUX DISEASE 1
PS NAUSEA LOWER GASTROINTESTINAL HAEMORRHAGE 1
PS NAUSEA VOMITING 1
PS NON-SMALL CELL LUNG CANCER ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS 3
PS NON-SMALL CELL LUNG CANCER MIXED LIVER INJURY 3
PS OCCUPATIONAL EXPOSURE TO DRUG ACCIDENTAL EXPOSURE 1
PS OCCUPATIONAL EXPOSURE TO DRUG APPLICATION SITE VESICLES 1
PS OCCUPATIONAL EXPOSURE TO DRUG THERMAL BURN 1
PS RECTAL CANCER DEATH 1
PS RECTAL CANCER DECREASED APPETITE 3
PS RECTAL CANCER DEHYDRATION 3
PS RECTAL CANCER DEVICE RELATED INFECTION 3
PS RECTAL CANCER DIARRHOEA 3
PS RECTAL CANCER GASTRITIS EROSIVE 3
PS RECTAL CANCER GASTROOESOPHAGEAL REFLUX DISEASE 3
PS RECTAL CANCER LOWER GASTROINTESTINAL HAEMORRHAGE 3
PS RECTAL CANCER VOMITING 3
PS RECTAL CANCER STAGE III BLOOD MAGNESIUM DECREASED 1
PS RECTAL CANCER STAGE III DEATH 1
PS RECTAL CANCER STAGE III DEHYDRATION 1
PS RECTAL CANCER STAGE III DIARRHOEA 1
SS ADENOCARCINOMA ANAEMIA 2
SS ADENOCARCINOMA GASTROINTESTINAL HAEMORRHAGE 2
SS ADENOCARCINOMA THROMBOPHLEBITIS SUPERFICIAL 2
SS COLON CANCER ABDOMINAL PAIN 2
SS COLON CANCER BLINDNESS 8
SS COLON CANCER BLINDNESS TRANSIENT 3
SS COLON CANCER CHEST PAIN 9
SS COLON CANCER DISEASE PROGRESSION 1
SS COLON CANCER DYSPNOEA 9
SS COLON CANCER HYPERHIDROSIS 9
SS COLON CANCER MULTIFOCAL MOTOR NEUROPATHY 3
SS COLON CANCER VITAL FUNCTIONS ABNORMAL 9
SS COLON CANCER METASTATIC RENAL FAILURE 4
SS COLON CANCER METASTATIC RENAL TUBULAR NECROSIS 4
SS COLORECTAL CANCER EXTRAVASATION 2
SS COLORECTAL CANCER SKIN INDURATION 2
SS COLORECTAL CANCER METASTATIC PARAESTHESIA 5
SS ENTERITIS DECREASED APPETITE 1
SS ENTERITIS DEHYDRATION 1
SS ENTERITIS DEVICE RELATED INFECTION 1
SS ENTERITIS DIARRHOEA 1
SS ENTERITIS GASTRITIS EROSIVE 1
SS ENTERITIS GASTROOESOPHAGEAL REFLUX DISEASE 1
SS ENTERITIS LOWER GASTROINTESTINAL HAEMORRHAGE 1
SS ENTERITIS VOMITING 1
SS GASTROINTESTINAL INFLAMMATION DECREASED APPETITE 1
SS GASTROINTESTINAL INFLAMMATION DEHYDRATION 1
SS GASTROINTESTINAL INFLAMMATION DEVICE RELATED INFECTION 1
SS GASTROINTESTINAL INFLAMMATION DIARRHOEA 1
SS GASTROINTESTINAL INFLAMMATION GASTRITIS EROSIVE 1
SS GASTROINTESTINAL INFLAMMATION GASTROOESOPHAGEAL REFLUX DISEASE 1
SS GASTROINTESTINAL INFLAMMATION LOWER GASTROINTESTINAL HAEMORRHAGE 1
SS GASTROINTESTINAL INFLAMMATION VOMITING 1
SS MALNUTRITION DECREASED APPETITE 3
SS MALNUTRITION DEHYDRATION 3
SS MALNUTRITION DEVICE RELATED INFECTION 3
SS MALNUTRITION DIARRHOEA 3
SS MALNUTRITION GASTRITIS EROSIVE 3
SS MALNUTRITION GASTROOESOPHAGEAL REFLUX DISEASE 3
SS MALNUTRITION LOWER GASTROINTESTINAL HAEMORRHAGE 3
SS MALNUTRITION VOMITING 3
SS METASTASES TO LIVER ABDOMINAL PAIN 8
SS METASTASES TO LIVER DECREASED APPETITE 8
SS METASTASES TO LIVER FEBRILE NEUTROPENIA 8
SS METASTASES TO LIVER PYELONEPHRITIS 8
SS NAUSEA DECREASED APPETITE 1
SS NAUSEA DEHYDRATION 1
SS NAUSEA DEVICE RELATED INFECTION 1
SS NAUSEA DIARRHOEA 1
SS NAUSEA GASTRITIS EROSIVE 1
SS NAUSEA GASTROOESOPHAGEAL REFLUX DISEASE 1
SS NAUSEA LOWER GASTROINTESTINAL HAEMORRHAGE 1
SS NAUSEA VOMITING 1
SS PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE 4
SS PRODUCT USED FOR UNKNOWN INDICATION RENAL TUBULAR NECROSIS 4
SS RECTAL CANCER DECREASED APPETITE 3
SS RECTAL CANCER DEHYDRATION 3
SS RECTAL CANCER DEVICE RELATED INFECTION 3
SS RECTAL CANCER DIARRHOEA 3
SS RECTAL CANCER GASTRITIS EROSIVE 3
SS RECTAL CANCER GASTROOESOPHAGEAL REFLUX DISEASE 3
SS RECTAL CANCER LOWER GASTROINTESTINAL HAEMORRHAGE 3
SS RECTAL CANCER VOMITING 3
SS THROMBOPHLEBITIS SUPERFICIAL ANAEMIA 2
SS THROMBOPHLEBITIS SUPERFICIAL GASTROINTESTINAL HAEMORRHAGE 2
SS THROMBOPHLEBITIS SUPERFICIAL THROMBOPHLEBITIS SUPERFICIAL 2
SS THROMBOSIS PROPHYLAXIS RENAL FAILURE 1
SS THROMBOSIS PROPHYLAXIS RENAL TUBULAR NECROSIS 1
C COLON CANCER ABDOMINAL PAIN 1
C COLON CANCER ABDOMINAL RIGIDITY 1
C COLON CANCER CARDIOGENIC SHOCK 3
C COLON CANCER PULMONARY EMBOLISM 3
C LEUKOPENIA WHITE BLOOD CELL COUNT DECREASED 2
C NON-SMALL CELL LUNG CANCER ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS 1
C NON-SMALL CELL LUNG CANCER HEPATOCELLULAR INJURY 1
C NON-SMALL CELL LUNG CANCER PANCYTOPENIA 1
Ads by Google