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EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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