Drug information for FENTORA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; BUCCAL EQ 0.1MG BASE Prescription AB  FENTANYL CITRATE Fentanyl CEPHALON 21947
2012-01-03 Letter

2011-12-30 Other

2011-12-28 Label

2011-07-21 Other

2011-07-21 Letter

2011-07-21 Label

2011-01-25 Letter

2011-01-24 Label

2010-01-25 Letter

2009-12-11 Label

2008-02-14 Letter

2008-02-14 Label

2007-12-06 Review

2007-09-26 Other Important Information from FDA

2007-05-01 Label

2007-05-01 Letter

2007-03-07 Letter

2007-03-07 Label

2007-02-20 Medication Guide

2006-10-02 Letter

2006-09-26 Label
TABLET; BUCCAL EQ 0.2MG BASE Prescription AB  FENTANYL CITRATE Fentanyl CEPHALON   "
TABLET; BUCCAL EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Discontinued   FENTANYL CITRATE Fentanyl CEPHALON   "
TABLET; BUCCAL EQ 0.4MG BASE Prescription AB (Reference Drug) FENTANYL CITRATE Fentanyl CEPHALON   "
TABLET; BUCCAL EQ 0.6MG BASE Prescription AB  FENTANYL CITRATE Fentanyl CEPHALON   "
TABLET; BUCCAL EQ 0.8MG BASE Prescription AB  FENTANYL CITRATE Fentanyl CEPHALON   "

Drug Adverse Effects information for FENTORA

Role code Indications Reaction # Reports
PS BONE CANCER METASTATIC APPLICATION SITE REACTION 1
PS BONE CANCER METASTATIC DIABETES MELLITUS 1
PS BONE CANCER METASTATIC DRUG INEFFECTIVE 1
PS BONE CANCER METASTATIC DRUG PRESCRIBING ERROR 1
PS BONE CANCER METASTATIC DRY MOUTH 1
PS COMPLEX REGIONAL PAIN SYNDROME ANTICONVULSANT DRUG LEVEL DECREASED 1
PS COMPLEX REGIONAL PAIN SYNDROME CONVULSION 1
PS COMPLEX REGIONAL PAIN SYNDROME DRUG INTERACTION 1
PS COMPLEX REGIONAL PAIN SYNDROME WEIGHT DECREASED 1
PS CONVULSION ANTICONVULSANT DRUG LEVEL DECREASED 2
PS CONVULSION CONVULSION 2
PS CONVULSION DRUG INTERACTION 2
PS CONVULSION WEIGHT DECREASED 2
PS GASTROINTESTINAL PAIN ASTHENIA 1
PS GASTROINTESTINAL PAIN COMPLICATIONS OF TRANSPLANT SURGERY 1
PS GASTROINTESTINAL PAIN FISTULA DISCHARGE 1
PS GASTROINTESTINAL PAIN INFECTION 1
PS GASTROINTESTINAL PAIN ORGAN TRANSPLANT 1
PS GASTROINTESTINAL PAIN THROMBOSIS 1
PS GASTROOESOPHAGEAL REFLUX DISEASE ANTICONVULSANT DRUG LEVEL DECREASED 1
PS GASTROOESOPHAGEAL REFLUX DISEASE CONVULSION 1
PS GASTROOESOPHAGEAL REFLUX DISEASE DRUG INTERACTION 1
PS GASTROOESOPHAGEAL REFLUX DISEASE WEIGHT DECREASED 1
PS PAIN ANTICONVULSANT DRUG LEVEL DECREASED 2
PS PAIN CONVULSION 2
PS PAIN DEPRESSION 1
PS PAIN DRUG INTERACTION 2
PS PAIN SUICIDAL IDEATION 1
PS PAIN WEIGHT DECREASED 2
PS PANCREATITIS CHRONIC PANCREATITIS 1
PS PELVIC PAIN DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 1
PS PELVIC PAIN DRUG PRESCRIBING ERROR 1
PS PELVIC PAIN EUPHORIC MOOD 1
PS PELVIC PAIN PAIN 1
PS SLEEP DISORDER ANTICONVULSANT DRUG LEVEL DECREASED 1
PS SLEEP DISORDER CONVULSION 1
PS SLEEP DISORDER DRUG INTERACTION 1
PS SLEEP DISORDER WEIGHT DECREASED 1
SS BREAST CANCER HOT FLUSH 1
SS BREAST CANCER HYPERHIDROSIS 1
SS COMPLEX REGIONAL PAIN SYNDROME ANTICONVULSANT DRUG LEVEL DECREASED 1
SS COMPLEX REGIONAL PAIN SYNDROME CONVULSION 1
SS COMPLEX REGIONAL PAIN SYNDROME DRUG INTERACTION 1
SS COMPLEX REGIONAL PAIN SYNDROME WEIGHT DECREASED 1
SS CONVULSION ANTICONVULSANT DRUG LEVEL DECREASED 2
SS CONVULSION CONVULSION 2
SS CONVULSION DRUG INTERACTION 2
SS CONVULSION WEIGHT DECREASED 2
SS GASTROOESOPHAGEAL REFLUX DISEASE ANTICONVULSANT DRUG LEVEL DECREASED 1
SS GASTROOESOPHAGEAL REFLUX DISEASE CONVULSION 1
SS GASTROOESOPHAGEAL REFLUX DISEASE DRUG INTERACTION 1
SS GASTROOESOPHAGEAL REFLUX DISEASE WEIGHT DECREASED 1
SS PAIN ANTICONVULSANT DRUG LEVEL DECREASED 2
SS PAIN CONVULSION 2
SS PAIN DRUG INTERACTION 2
SS PAIN WEIGHT DECREASED 2
SS PELVIC PAIN DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 1
SS PELVIC PAIN DRUG PRESCRIBING ERROR 1
SS PELVIC PAIN EUPHORIC MOOD 1
SS PELVIC PAIN PAIN 1
SS SLEEP DISORDER ANTICONVULSANT DRUG LEVEL DECREASED 1
SS SLEEP DISORDER CONVULSION 1
SS SLEEP DISORDER DRUG INTERACTION 1
SS SLEEP DISORDER WEIGHT DECREASED 1
SS SYSTEMIC LUPUS ERYTHEMATOSUS HOT FLUSH 1
SS SYSTEMIC LUPUS ERYTHEMATOSUS HYPERHIDROSIS 1
C PANCREATIC CARCINOMA ANAEMIA 2
C PANCREATIC CARCINOMA GASTROINTESTINAL HAEMORRHAGE 2
C PRODUCT USED FOR UNKNOWN INDICATION ANAEMIA 6
C PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL HAEMORRHAGE 6
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